Trial Outcomes & Findings for A Dose Response Study of E6011 in Participants With Rheumatoid Arthritis Inadequately Responding to Methotrexate (NCT NCT02960438)

NCT ID: NCT02960438

Last Updated: 2021-06-21

Results Overview

The ACR20 response was defined as if the following 3 criteria (ACR components) were met: Greater than or equal to (\>=) 20 percent (%) reduction from baseline in the tender joint count (TJC) in 68 joints (TJC68); \>=20% reduction from baseline in the swollen joint count (SJC) in 66 joints (SJC66); \>=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (visual analog scale \[VAS\]) , Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), Health Assessment Questionnaire disability index (HAQ-DI), and C-reactive protein (CRP).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 273 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2021-06-21

Participant Flow

Participants took part in the study at 91 investigative sites in Japan from 20 October 2016 to 17 September 2019.

A total of 273 participants were screened and enrolled (signed informed consent form), of which 79 were screen failures, and 194 were randomized out which 190 received study treatment.

Participant milestones

Measure	Placebo During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 milligram (mg), infusion, subcutaneously, every 2 weeks until Week 102.	E6011 100 mg During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	E6011 200 mg During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	E6011 400/200 mg During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Treatment Phase (Double-blind): 24 Weeks STARTED	56	29	54	55
Treatment Phase (Double-blind): 24 Weeks Treated Participants	54	28	54	54
Treatment Phase (Double-blind): 24 Weeks COMPLETED	47	26	50	46
Treatment Phase (Double-blind): 24 Weeks NOT COMPLETED	9	3	4	9
Extension Phase (Open-label): 80 Weeks STARTED	47	26	50	46
Extension Phase (Open-label): 80 Weeks COMPLETED	36	17	36	35
Extension Phase (Open-label): 80 Weeks NOT COMPLETED	11	9	14	11

Reasons for withdrawal

Measure	Placebo During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 milligram (mg), infusion, subcutaneously, every 2 weeks until Week 102.	E6011 100 mg During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	E6011 200 mg During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	E6011 400/200 mg During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Treatment Phase (Double-blind): 24 Weeks Inadequate Therapeutic Effect	2	1	2	5
Treatment Phase (Double-blind): 24 Weeks Adverse Event	2	1	0	3
Treatment Phase (Double-blind): 24 Weeks Progression of Disease	2	0	0	0
Treatment Phase (Double-blind): 24 Weeks Withdrawal by Subject	1	0	1	0
Treatment Phase (Double-blind): 24 Weeks Other	0	0	1	0
Treatment Phase (Double-blind): 24 Weeks Not Treated	2	1	0	1
Extension Phase (Open-label): 80 Weeks Adverse Event	1	2	4	1
Extension Phase (Open-label): 80 Weeks Lost to Follow-up	0	0	1	0
Extension Phase (Open-label): 80 Weeks Withdrawal by Subject	1	1	0	1
Extension Phase (Open-label): 80 Weeks Inadequate Therapeutic Effect	7	5	7	6
Extension Phase (Open-label): 80 Weeks Progression of Disease	2	1	1	2
Extension Phase (Open-label): 80 Weeks Other	0	0	1	1

Baseline Characteristics

A Dose Response Study of E6011 in Participants With Rheumatoid Arthritis Inadequately Responding to Methotrexate

Baseline characteristics by cohort

Measure	Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Total n=190 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 9.86 • n=5 Participants	56.5 years STANDARD_DEVIATION 10.40 • n=7 Participants	56.5 years STANDARD_DEVIATION 10.39 • n=5 Participants	55.2 years STANDARD_DEVIATION 9.13 • n=4 Participants	56.4 years STANDARD_DEVIATION 9.86 • n=21 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants	39 Participants n=4 Participants	150 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	15 Participants n=4 Participants	40 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants	54 Participants n=4 Participants	190 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Japanese	54 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants	54 Participants n=4 Participants	190 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 12

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Missing data was imputed using NRI and this Outcome Measure was planned to be assessed only in Treatment Phase.

The ACR20 response was defined as if the following 3 criteria (ACR components) were met: Greater than or equal to (>=) 20 percent (%) reduction from baseline in the tender joint count (TJC) in 68 joints (TJC68); >=20% reduction from baseline in the swollen joint count (SJC) in 66 joints (SJC66); >=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (visual analog scale [VAS]) , Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), Health Assessment Questionnaire disability index (HAQ-DI), and C-reactive protein (CRP).

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology 20 (ACR20) Response at Week 12 Based on Non-responder Imputation (NRI)	37.0 percentage of participants Interval 24.16 to 49.92	39.3 percentage of participants Interval 21.2 to 57.38	48.1 percentage of participants Interval 34.82 to 61.47	46.3 percentage of participants Interval 33.0 to 59.6	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 16, 20, and 24

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Missing data was imputed using NRI and this Outcome Measure was planned to be assessed only in Treatment Phase.

The ACR20 response was defined as if the following 3 criteria (ACR components) were met: >=20% reduction from baseline in the TJC in 68 joints (TJC68); >=20% reduction from baseline in the SJC in 66 joints (SJC66); >=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 2	13.0 percentage of participants Interval 4.0 to 21.92	14.3 percentage of participants Interval 1.32 to 27.25	22.2 percentage of participants Interval 11.13 to 33.31	20.4 percentage of participants Interval 9.63 to 31.11	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 8	40.7 percentage of participants Interval 27.64 to 53.85	35.7 percentage of participants Interval 17.97 to 53.46	37.0 percentage of participants Interval 24.16 to 49.92	46.3 percentage of participants Interval 33.0 to 59.6	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 16	46.3 percentage of participants Interval 33.0 to 59.6	46.4 percentage of participants Interval 27.96 to 64.9	51.9 percentage of participants Interval 38.53 to 65.18	53.7 percentage of participants Interval 40.4 to 67.0	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 24	35.2 percentage of participants Interval 22.45 to 47.92	39.3 percentage of participants Interval 21.2 to 57.38	53.7 percentage of participants Interval 40.4 to 67.0	57.4 percentage of participants Interval 44.22 to 70.6	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 4	18.5 percentage of participants Interval 8.16 to 28.88	28.6 percentage of participants Interval 11.84 to 45.3	24.1 percentage of participants Interval 12.67 to 35.48	31.5 percentage of participants Interval 19.09 to 43.87	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 20	33.3 percentage of participants Interval 20.76 to 45.91	50.0 percentage of participants Interval 31.48 to 68.52	59.3 percentage of participants Interval 46.15 to 72.36	55.6 percentage of participants Interval 42.3 to 68.81	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 16, 20, and 24

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Missing data was imputed using NRI and this Outcome Measure was planned to be assessed only in Treatment Phase.

The ACR50 response was defined as if the following 3 criteria (ACR components) were met: >=50% reduction from baseline in the TJC in 68 joints (TJC68); >=50% reduction from baseline in the SJC in 66 joints (SJC66); >=50% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 2	1.9 percentage of participants Interval 0.0 to 5.45	0.0 percentage of participants Interval 0.0 to 0.0	7.4 percentage of participants Interval 0.42 to 14.39	7.4 percentage of participants Interval 0.42 to 14.39	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 4	0.0 percentage of participants Interval 0.0 to 0.0	3.6 percentage of participants Interval 0.0 to 10.45	3.7 percentage of participants Interval 0.0 to 8.74	9.3 percentage of participants Interval 1.53 to 16.99	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 8	7.4 percentage of participants Interval 0.42 to 14.39	14.3 percentage of participants Interval 1.32 to 27.25	3.7 percentage of participants Interval 0.0 to 8.74	9.3 percentage of participants Interval 1.53 to 16.99	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 12	14.8 percentage of participants Interval 5.34 to 24.29	10.7 percentage of participants Interval 0.0 to 22.17	25.9 percentage of participants Interval 14.24 to 37.61	18.5 percentage of participants Interval 8.16 to 28.88	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 16	14.8 percentage of participants Interval 5.34 to 24.29	17.9 percentage of participants Interval 3.67 to 32.04	20.4 percentage of participants Interval 9.63 to 31.11	22.2 percentage of participants Interval 11.13 to 33.31	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 20	14.8 percentage of participants Interval 5.34 to 24.29	10.7 percentage of participants Interval 0.0 to 22.17	31.5 percentage of participants Interval 19.09 to 43.87	25.9 percentage of participants Interval 14.24 to 37.61	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 24	16.7 percentage of participants Interval 6.73 to 26.61	17.9 percentage of participants Interval 3.67 to 32.04	25.9 percentage of participants Interval 14.24 to 37.61	27.8 percentage of participants Interval 15.83 to 39.72	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 16, 20, and 24

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Missing data was imputed using NRI and this Outcome Measure was planned to be assessed only in Treatment Phase.

The ACR70 response was defined as if the following 3 criteria (ACR components) were met: >=70% reduction from baseline in the TJC in 68 joints (TJC68); >=70% reduction from baseline in the SJC in 66 joints (SJC66); >=70% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 8	1.9 percentage of participants Interval 0.0 to 5.45	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	5.6 percentage of participants Interval 0.0 to 11.67	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 16	5.6 percentage of participants Interval 0.0 to 11.67	7.1 percentage of participants Interval 0.0 to 16.68	3.7 percentage of participants Interval 0.0 to 8.74	13.0 percentage of participants Interval 4.0 to 21.92	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 20	5.6 percentage of participants Interval 0.0 to 11.67	7.1 percentage of participants Interval 0.0 to 16.68	11.1 percentage of participants Interval 2.73 to 19.49	14.8 percentage of participants Interval 5.34 to 24.29	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 2	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	1.9 percentage of participants Interval 0.0 to 5.45	0.0 percentage of participants Interval 0.0 to 0.0	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 4	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	1.9 percentage of participants Interval 0.0 to 5.45	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 12	3.7 percentage of participants Interval 0.0 to 8.74	3.6 percentage of participants Interval 0.0 to 10.45	9.3 percentage of participants Interval 1.53 to 16.99	7.4 percentage of participants Interval 0.42 to 14.39	—	—	—	—
Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI Response at Week 24	5.6 percentage of participants Interval 0.0 to 11.67	14.3 percentage of participants Interval 1.32 to 27.25	11.1 percentage of participants Interval 2.73 to 19.49	13.0 percentage of participants Interval 4.0 to 21.92	—	—	—	—

SECONDARY outcome

Timeframe: Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.

A total of 68 joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Tender joints were marked with tick or cross in corresponding frames of the Assessment Sheet for Tender Joint Counts. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 40	—	—	—	—	-8.3 tender joints Standard Deviation 8.98	-7.5 tender joints Standard Deviation 6.59	-9.9 tender joints Standard Deviation 6.79	-10.7 tender joints Standard Deviation 9.95
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 2	-2.9 tender joints Standard Deviation 5.63	-2.7 tender joints Standard Deviation 5.05	-3.6 tender joints Standard Deviation 5.99	-3.9 tender joints Standard Deviation 6.00	-3.2 tender joints Standard Deviation 4.88	-2.5 tender joints Standard Deviation 5.01	-3.4 tender joints Standard Deviation 5.99	-4.5 tender joints Standard Deviation 6.27
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 4	-2.9 tender joints Standard Deviation 6.04	-2.9 tender joints Standard Deviation 4.47	-4.5 tender joints Standard Deviation 5.34	-5.8 tender joints Standard Deviation 7.68	-3.0 tender joints Standard Deviation 5.63	-2.8 tender joints Standard Deviation 4.44	-4.5 tender joints Standard Deviation 5.29	-6.7 tender joints Standard Deviation 7.62
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 8	-3.9 tender joints Standard Deviation 7.00	-4.6 tender joints Standard Deviation 5.55	-5.7 tender joints Standard Deviation 6.14	-6.7 tender joints Standard Deviation 9.30	-4.7 tender joints Standard Deviation 6.12	-4.6 tender joints Standard Deviation 5.36	-5.7 tender joints Standard Deviation 5.98	-7.6 tender joints Standard Deviation 9.55
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 12	-4.2 tender joints Standard Deviation 7.40	-5.2 tender joints Standard Deviation 6.83	-7.1 tender joints Standard Deviation 7.42	-7.9 tender joints Standard Deviation 9.77	-5.0 tender joints Standard Deviation 6.54	-5.3 tender joints Standard Deviation 6.83	-7.3 tender joints Standard Deviation 7.18	-8.9 tender joints Standard Deviation 10.10
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 16	-5.3 tender joints Standard Deviation 7.51	-6.4 tender joints Standard Deviation 7.34	-8.4 tender joints Standard Deviation 6.53	-7.9 tender joints Standard Deviation 10.33	-6.3 tender joints Standard Deviation 6.53	-6.6 tender joints Standard Deviation 7.36	-8.6 tender joints Standard Deviation 6.20	-9.3 tender joints Standard Deviation 9.95
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 20	-5.6 tender joints Standard Deviation 8.50	-6.9 tender joints Standard Deviation 7.33	-7.6 tender joints Standard Deviation 7.72	-8.5 tender joints Standard Deviation 9.68	-6.8 tender joints Standard Deviation 7.70	-7.2 tender joints Standard Deviation 7.31	-7.8 tender joints Standard Deviation 7.59	-10.0 tender joints Standard Deviation 9.06
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 44	—	—	—	—	-7.5 tender joints Standard Deviation 8.12	-7.4 tender joints Standard Deviation 6.33	-9.9 tender joints Standard Deviation 7.53	-11.4 tender joints Standard Deviation 10.59
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 48	—	—	—	—	-7.3 tender joints Standard Deviation 9.30	-8.2 tender joints Standard Deviation 6.59	-9.4 tender joints Standard Deviation 7.98	-10.9 tender joints Standard Deviation 10.33
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 56	—	—	—	—	-7.9 tender joints Standard Deviation 7.65	-7.7 tender joints Standard Deviation 6.71	-9.1 tender joints Standard Deviation 7.62	-11.0 tender joints Standard Deviation 8.98
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 60	—	—	—	—	-8.0 tender joints Standard Deviation 8.03	-8.4 tender joints Standard Deviation 6.24	-10.0 tender joints Standard Deviation 8.14	-11.5 tender joints Standard Deviation 9.18
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 72	—	—	—	—	-8.3 tender joints Standard Deviation 8.23	-7.9 tender joints Standard Deviation 6.39	-9.8 tender joints Standard Deviation 7.80	-11.2 tender joints Standard Deviation 10.02
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 76	—	—	—	—	-8.2 tender joints Standard Deviation 8.12	-8.2 tender joints Standard Deviation 6.63	-10.5 tender joints Standard Deviation 7.88	-11.8 tender joints Standard Deviation 9.10
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 80	—	—	—	—	-8.2 tender joints Standard Deviation 8.29	-8.5 tender joints Standard Deviation 6.37	-10.5 tender joints Standard Deviation 7.77	-11.8 tender joints Standard Deviation 9.74
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 84	—	—	—	—	-8.2 tender joints Standard Deviation 8.08	-8.0 tender joints Standard Deviation 6.26	-10.5 tender joints Standard Deviation 7.79	-11.7 tender joints Standard Deviation 9.99
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 28	—	—	—	—	-7.6 tender joints Standard Deviation 7.85	-7.5 tender joints Standard Deviation 7.40	-9.5 tender joints Standard Deviation 7.74	-10.1 tender joints Standard Deviation 9.92
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Baseline	13.7 tender joints Standard Deviation 6.81	14.1 tender joints Standard Deviation 7.24	16.3 tender joints Standard Deviation 7.15	16.6 tender joints Standard Deviation 9.61	13.6 tender joints Standard Deviation 6.72	14.3 tender joints Standard Deviation 7.49	15.7 tender joints Standard Deviation 6.70	16.6 tender joints Standard Deviation 9.07
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 32	—	—	—	—	-8.4 tender joints Standard Deviation 7.94	-7.9 tender joints Standard Deviation 7.00	-8.6 tender joints Standard Deviation 7.94	-10.0 tender joints Standard Deviation 9.64
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 36	—	—	—	—	-8.1 tender joints Standard Deviation 9.25	-7.6 tender joints Standard Deviation 6.86	-9.4 tender joints Standard Deviation 6.85	-11.3 tender joints Standard Deviation 10.32
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 52	—	—	—	—	-7.6 tender joints Standard Deviation 7.90	-8.0 tender joints Standard Deviation 6.68	-10.2 tender joints Standard Deviation 6.44	-10.7 tender joints Standard Deviation 9.44
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 64	—	—	—	—	-8.4 tender joints Standard Deviation 8.70	-8.7 tender joints Standard Deviation 6.24	-9.0 tender joints Standard Deviation 7.86	-12.1 tender joints Standard Deviation 8.76
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 68	—	—	—	—	-8.5 tender joints Standard Deviation 8.15	-7.5 tender joints Standard Deviation 6.84	-9.7 tender joints Standard Deviation 8.45	-12.0 tender joints Standard Deviation 9.58
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) Change at Week 24	-5.6 tender joints Standard Deviation 7.97	-6.9 tender joints Standard Deviation 7.55	-8.6 tender joints Standard Deviation 7.38	-8.7 tender joints Standard Deviation 9.93	-6.8 tender joints Standard Deviation 7.02	-7.2 tender joints Standard Deviation 7.55	-8.9 tender joints Standard Deviation 7.13	-10.4 tender joints Standard Deviation 9.36

SECONDARY outcome

Timeframe: Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.

A total of 66 joints (minus 2 hip joints from evaluated tender joints) were examined for swollen joints. Swollen joints were marked with open circles in corresponding frames of the Assessment Sheet for Swollen Joint Counts. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Baseline	12.7 swollen joints Standard Deviation 6.81	11.3 swollen joints Standard Deviation 5.27	12.4 swollen joints Standard Deviation 4.89	13.5 swollen joints Standard Deviation 6.41	12.7 swollen joints Standard Deviation 6.48	11.5 swollen joints Standard Deviation 5.38	12.1 swollen joints Standard Deviation 4.63	13.8 swollen joints Standard Deviation 6.18
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 2	-2.2 swollen joints Standard Deviation 4.70	-2.8 swollen joints Standard Deviation 3.33	-2.9 swollen joints Standard Deviation 4.18	-3.4 swollen joints Standard Deviation 5.25	-2.9 swollen joints Standard Deviation 4.21	-2.9 swollen joints Standard Deviation 3.46	-3.0 swollen joints Standard Deviation 3.84	-3.7 swollen joints Standard Deviation 5.17
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 4	-3.0 swollen joints Standard Deviation 5.36	-3.7 swollen joints Standard Deviation 3.42	-3.3 swollen joints Standard Deviation 4.66	-5.0 swollen joints Standard Deviation 4.95	-3.8 swollen joints Standard Deviation 3.94	-3.8 swollen joints Standard Deviation 3.51	-3.5 swollen joints Standard Deviation 4.03	-5.5 swollen joints Standard Deviation 5.01
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 8	-4.1 swollen joints Standard Deviation 7.33	-4.7 swollen joints Standard Deviation 4.16	-3.8 swollen joints Standard Deviation 5.82	-6.0 swollen joints Standard Deviation 5.81	-5.7 swollen joints Standard Deviation 4.70	-4.7 swollen joints Standard Deviation 4.32	-3.8 swollen joints Standard Deviation 5.42	-6.7 swollen joints Standard Deviation 5.74
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 12	-4.2 swollen joints Standard Deviation 7.05	-5.1 swollen joints Standard Deviation 4.91	-4.9 swollen joints Standard Deviation 5.39	-5.7 swollen joints Standard Deviation 6.41	-5.9 swollen joints Standard Deviation 4.11	-5.2 swollen joints Standard Deviation 5.08	-5.2 swollen joints Standard Deviation 4.93	-6.4 swollen joints Standard Deviation 6.34
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 16	-4.3 swollen joints Standard Deviation 7.38	-6.1 swollen joints Standard Deviation 4.32	-5.2 swollen joints Standard Deviation 5.30	-6.6 swollen joints Standard Deviation 6.60	-6.0 swollen joints Standard Deviation 4.65	-6.3 swollen joints Standard Deviation 4.43	-5.5 swollen joints Standard Deviation 4.81	-8.0 swollen joints Standard Deviation 5.68
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 20	-5.1 swollen joints Standard Deviation 8.73	-6.4 swollen joints Standard Deviation 4.65	-5.6 swollen joints Standard Deviation 5.71	-6.4 swollen joints Standard Deviation 7.26	-7.0 swollen joints Standard Deviation 6.50	-6.6 swollen joints Standard Deviation 4.78	-5.8 swollen joints Standard Deviation 5.28	-7.7 swollen joints Standard Deviation 6.61
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 24	-5.1 swollen joints Standard Deviation 8.32	-6.3 swollen joints Standard Deviation 4.28	-5.9 swollen joints Standard Deviation 6.38	-6.2 swollen joints Standard Deviation 6.65	-7.0 swollen joints Standard Deviation 5.86	-6.5 swollen joints Standard Deviation 4.38	-6.2 swollen joints Standard Deviation 5.93	-7.6 swollen joints Standard Deviation 5.74
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-7.2 swollen joints Standard Deviation 6.77	-7.8 swollen joints Standard Deviation 5.05	-6.9 swollen joints Standard Deviation 5.71	-8.5 swollen joints Standard Deviation 5.98
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-7.9 swollen joints Standard Deviation 7.04	-7.6 swollen joints Standard Deviation 4.63	-7.0 swollen joints Standard Deviation 6.17	-8.6 swollen joints Standard Deviation 6.31
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-7.2 swollen joints Standard Deviation 7.52	-7.5 swollen joints Standard Deviation 4.64	-7.1 swollen joints Standard Deviation 5.90	-9.0 swollen joints Standard Deviation 5.75
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-7.4 swollen joints Standard Deviation 7.55	-7.2 swollen joints Standard Deviation 4.43	-6.8 swollen joints Standard Deviation 5.10	-8.4 swollen joints Standard Deviation 5.64
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-6.9 swollen joints Standard Deviation 7.75	-6.5 swollen joints Standard Deviation 4.54	-6.8 swollen joints Standard Deviation 5.44	-8.3 swollen joints Standard Deviation 6.32
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-7.2 swollen joints Standard Deviation 8.04	-6.7 swollen joints Standard Deviation 4.48	-6.4 swollen joints Standard Deviation 6.11	-8.5 swollen joints Standard Deviation 5.82
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-7.2 swollen joints Standard Deviation 7.19	-6.7 swollen joints Standard Deviation 4.54	-6.3 swollen joints Standard Deviation 5.03	-8.3 swollen joints Standard Deviation 5.30
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-7.4 swollen joints Standard Deviation 6.83	-7.3 swollen joints Standard Deviation 4.32	-6.5 swollen joints Standard Deviation 6.40	-8.5 swollen joints Standard Deviation 6.17
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-7.5 swollen joints Standard Deviation 7.67	-7.3 swollen joints Standard Deviation 4.61	-6.4 swollen joints Standard Deviation 6.21	-8.5 swollen joints Standard Deviation 5.75
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-8.0 swollen joints Standard Deviation 7.30	-6.5 swollen joints Standard Deviation 5.21	-6.9 swollen joints Standard Deviation 5.79	-8.6 swollen joints Standard Deviation 5.78
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-7.9 swollen joints Standard Deviation 7.49	-7.0 swollen joints Standard Deviation 4.76	-6.9 swollen joints Standard Deviation 5.93	-8.8 swollen joints Standard Deviation 5.68
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 76	—	—	—	—	-7.7 swollen joints Standard Deviation 7.21	-6.3 swollen joints Standard Deviation 4.77	-7.1 swollen joints Standard Deviation 5.81	-8.3 swollen joints Standard Deviation 5.59
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 80	—	—	—	—	-7.2 swollen joints Standard Deviation 7.50	-7.1 swollen joints Standard Deviation 4.89	-6.7 swollen joints Standard Deviation 6.18	-8.4 swollen joints Standard Deviation 6.07
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-7.3 swollen joints Standard Deviation 7.18	-7.0 swollen joints Standard Deviation 3.77	-6.3 swollen joints Standard Deviation 5.89	-8.6 swollen joints Standard Deviation 5.70
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF Change at Week 84	—	—	—	—	-7.7 swollen joints Standard Deviation 7.38	-7.2 swollen joints Standard Deviation 4.92	-6.9 swollen joints Standard Deviation 6.08	-8.2 swollen joints Standard Deviation 6.25

SECONDARY outcome

Timeframe: Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.

Intensity and severity of pain associated with rheumatoid arthritis (RA) were indicated by the participant on a score sheet, Pain/disease activity assessments reported by the participant, by placing a mark on a 100 millimeter (mm) horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Baseline	53.6 units on a scale Standard Deviation 23.03	47.9 units on a scale Standard Deviation 26.37	46.6 units on a scale Standard Deviation 23.03	52.9 units on a scale Standard Deviation 24.38	54.2 units on a scale Standard Deviation 21.89	46.6 units on a scale Standard Deviation 26.94	46.7 units on a scale Standard Deviation 22.95	49.6 units on a scale Standard Deviation 24.25
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 2	-4.0 units on a scale Standard Deviation 17.96	-4.5 units on a scale Standard Deviation 12.64	-6.2 units on a scale Standard Deviation 17.22	-5.9 units on a scale Standard Deviation 16.91	-5.2 units on a scale Standard Deviation 18.88	-4.4 units on a scale Standard Deviation 13.08	-6.4 units on a scale Standard Deviation 17.81	-5.1 units on a scale Standard Deviation 17.00
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 4	-5.8 units on a scale Standard Deviation 22.47	-6.4 units on a scale Standard Deviation 20.68	-4.1 units on a scale Standard Deviation 18.36	-9.0 units on a scale Standard Deviation 18.93	-9.0 units on a scale Standard Deviation 21.34	-6.6 units on a scale Standard Deviation 21.47	-4.4 units on a scale Standard Deviation 18.77	-8.3 units on a scale Standard Deviation 19.19
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 8	-7.8 units on a scale Standard Deviation 20.76	-4.9 units on a scale Standard Deviation 19.96	-10.0 units on a scale Standard Deviation 18.29	-16.6 units on a scale Standard Deviation 22.58	-10.5 units on a scale Standard Deviation 18.73	-5.7 units on a scale Standard Deviation 20.51	-11.0 units on a scale Standard Deviation 18.45	-17.0 units on a scale Standard Deviation 23.50
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 12	-7.5 units on a scale Standard Deviation 26.09	-12.2 units on a scale Standard Deviation 18.19	-12.9 units on a scale Standard Deviation 21.24	-13.7 units on a scale Standard Deviation 25.24	-11.0 units on a scale Standard Deviation 25.10	-12.8 units on a scale Standard Deviation 18.75	-14.6 units on a scale Standard Deviation 20.72	-15.2 units on a scale Standard Deviation 26.57
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 16	-10.8 units on a scale Standard Deviation 27.25	-11.4 units on a scale Standard Deviation 19.69	-13.6 units on a scale Standard Deviation 20.87	-15.1 units on a scale Standard Deviation 25.78	-14.1 units on a scale Standard Deviation 26.26	-11.7 units on a scale Standard Deviation 20.42	-14.8 units on a scale Standard Deviation 20.91	-17.8 units on a scale Standard Deviation 26.62
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 20	-9.1 units on a scale Standard Deviation 29.43	-13.5 units on a scale Standard Deviation 19.33	-15.0 units on a scale Standard Deviation 21.08	-16.6 units on a scale Standard Deviation 26.04	-12.9 units on a scale Standard Deviation 28.35	-14.4 units on a scale Standard Deviation 19.75	-16.6 units on a scale Standard Deviation 20.67	-19.3 units on a scale Standard Deviation 26.67
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 24	-9.4 units on a scale Standard Deviation 28.49	-13.9 units on a scale Standard Deviation 21.59	-14.4 units on a scale Standard Deviation 20.85	-18.5 units on a scale Standard Deviation 24.29	-13.2 units on a scale Standard Deviation 27.17	-14.8 units on a scale Standard Deviation 22.11	-16.0 units on a scale Standard Deviation 20.47	-21.6 units on a scale Standard Deviation 24.35
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-18.0 units on a scale Standard Deviation 26.34	-12.9 units on a scale Standard Deviation 25.13	-14.0 units on a scale Standard Deviation 22.45	-22.3 units on a scale Standard Deviation 27.16
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-17.9 units on a scale Standard Deviation 27.27	-16.9 units on a scale Standard Deviation 23.06	-14.6 units on a scale Standard Deviation 22.57	-21.0 units on a scale Standard Deviation 33.28
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-15.5 units on a scale Standard Deviation 28.89	-14.4 units on a scale Standard Deviation 23.58	-16.8 units on a scale Standard Deviation 25.04	-22.2 units on a scale Standard Deviation 31.15
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-15.3 units on a scale Standard Deviation 28.08	-15.5 units on a scale Standard Deviation 23.14	-17.7 units on a scale Standard Deviation 23.93	-22.7 units on a scale Standard Deviation 29.17
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-16.7 units on a scale Standard Deviation 26.93	-17.8 units on a scale Standard Deviation 21.77	-17.5 units on a scale Standard Deviation 23.27	-23.1 units on a scale Standard Deviation 29.58
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-20.0 units on a scale Standard Deviation 27.74	-17.6 units on a scale Standard Deviation 24.36	-17.6 units on a scale Standard Deviation 22.50	-23.4 units on a scale Standard Deviation 28.36
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-17.2 units on a scale Standard Deviation 28.24	-15.3 units on a scale Standard Deviation 25.63	-16.9 units on a scale Standard Deviation 25.39	-22.7 units on a scale Standard Deviation 24.17
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-20.8 units on a scale Standard Deviation 27.88	-16.0 units on a scale Standard Deviation 25.02	-18.7 units on a scale Standard Deviation 22.74	-21.8 units on a scale Standard Deviation 24.98
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-22.6 units on a scale Standard Deviation 28.21	-16.2 units on a scale Standard Deviation 23.69	-18.0 units on a scale Standard Deviation 23.76	-24.6 units on a scale Standard Deviation 26.90
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-21.2 units on a scale Standard Deviation 26.46	-16.1 units on a scale Standard Deviation 24.34	-17.5 units on a scale Standard Deviation 26.63	-22.0 units on a scale Standard Deviation 26.80
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-24.6 units on a scale Standard Deviation 27.59	-17.7 units on a scale Standard Deviation 25.96	-16.2 units on a scale Standard Deviation 25.65	-24.1 units on a scale Standard Deviation 27.79
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-23.3 units on a scale Standard Deviation 27.81	-16.7 units on a scale Standard Deviation 24.96	-16.2 units on a scale Standard Deviation 25.49	-24.5 units on a scale Standard Deviation 27.82
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 76	—	—	—	—	-21.4 units on a scale Standard Deviation 27.70	-19.0 units on a scale Standard Deviation 26.29	-16.9 units on a scale Standard Deviation 25.92	-24.2 units on a scale Standard Deviation 28.00
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 80	—	—	—	—	-21.4 units on a scale Standard Deviation 29.20	-19.3 units on a scale Standard Deviation 25.29	-16.2 units on a scale Standard Deviation 25.09	-24.8 units on a scale Standard Deviation 25.53
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF Change at Week 84	—	—	—	—	-23.2 units on a scale Standard Deviation 28.58	-18.3 units on a scale Standard Deviation 26.01	-17.1 units on a scale Standard Deviation 24.50	-24.4 units on a scale Standard Deviation 27.29

SECONDARY outcome

Timeframe: Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.

Participants were evaluated on their disease activity of RA, and entered the result on the score sheet, disease activity assessments reported by the participant, by placing a mark on a 100 mm horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-16.1 units on a scale Standard Deviation 31.20	-17.0 units on a scale Standard Deviation 23.15	-19.4 units on a scale Standard Deviation 23.97	-24.6 units on a scale Standard Deviation 25.27
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Baseline	53.1 units on a scale Standard Deviation 25.74	50.1 units on a scale Standard Deviation 25.04	49.0 units on a scale Standard Deviation 22.37	54.5 units on a scale Standard Deviation 23.97	53.4 units on a scale Standard Deviation 25.30	49.2 units on a scale Standard Deviation 25.77	49.2 units on a scale Standard Deviation 22.19	51.3 units on a scale Standard Deviation 23.89
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 2	-2.9 units on a scale Standard Deviation 20.03	-4.2 units on a scale Standard Deviation 14.32	-8.3 units on a scale Standard Deviation 17.32	-6.4 units on a scale Standard Deviation 16.40	-3.8 units on a scale Standard Deviation 21.28	-4.5 units on a scale Standard Deviation 14.70	-8.5 units on a scale Standard Deviation 17.84	-5.5 units on a scale Standard Deviation 16.45
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 4	-6.4 units on a scale Standard Deviation 24.49	-6.6 units on a scale Standard Deviation 17.03	-7.2 units on a scale Standard Deviation 16.29	-9.8 units on a scale Standard Deviation 19.73	-9.4 units on a scale Standard Deviation 23.96	-7.0 units on a scale Standard Deviation 17.50	-7.6 units on a scale Standard Deviation 16.64	-9.5 units on a scale Standard Deviation 20.26
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 8	-5.5 units on a scale Standard Deviation 23.48	-7.3 units on a scale Standard Deviation 18.62	-11.6 units on a scale Standard Deviation 18.67	-18.1 units on a scale Standard Deviation 23.66	-7.5 units on a scale Standard Deviation 22.61	-8.5 units on a scale Standard Deviation 18.82	-12.8 units on a scale Standard Deviation 18.80	-18.8 units on a scale Standard Deviation 24.76
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 12	-7.3 units on a scale Standard Deviation 27.83	-14.6 units on a scale Standard Deviation 18.22	-15.2 units on a scale Standard Deviation 18.50	-15.1 units on a scale Standard Deviation 27.23	-10.0 units on a scale Standard Deviation 27.59	-15.8 units on a scale Standard Deviation 18.36	-17.0 units on a scale Standard Deviation 17.62	-17.3 units on a scale Standard Deviation 28.74
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 16	-11.6 units on a scale Standard Deviation 27.40	-14.0 units on a scale Standard Deviation 20.19	-16.1 units on a scale Standard Deviation 20.49	-16.6 units on a scale Standard Deviation 27.22	-14.7 units on a scale Standard Deviation 26.47	-15.3 units on a scale Standard Deviation 20.31	-17.4 units on a scale Standard Deviation 20.46	-19.3 units on a scale Standard Deviation 28.40
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 20	-10.0 units on a scale Standard Deviation 30.67	-15.3 units on a scale Standard Deviation 19.24	-17.4 units on a scale Standard Deviation 21.43	-17.8 units on a scale Standard Deviation 28.14	-13.6 units on a scale Standard Deviation 29.69	-17.0 units on a scale Standard Deviation 18.89	-19.2 units on a scale Standard Deviation 21.03	-20.7 units on a scale Standard Deviation 29.30
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 24	-8.8 units on a scale Standard Deviation 30.97	-15.3 units on a scale Standard Deviation 23.29	-17.8 units on a scale Standard Deviation 20.27	-20.4 units on a scale Standard Deviation 24.90	-12.3 units on a scale Standard Deviation 30.20	-17.0 units on a scale Standard Deviation 23.30	-19.6 units on a scale Standard Deviation 19.72	-23.8 units on a scale Standard Deviation 25.11
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-17.1 units on a scale Standard Deviation 30.18	-17.0 units on a scale Standard Deviation 24.50	-18.5 units on a scale Standard Deviation 21.28	-24.8 units on a scale Standard Deviation 27.56
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-19.3 units on a scale Standard Deviation 29.27	-19.8 units on a scale Standard Deviation 20.81	-16.7 units on a scale Standard Deviation 24.64	-23.2 units on a scale Standard Deviation 32.64
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-15.7 units on a scale Standard Deviation 28.40	-17.0 units on a scale Standard Deviation 22.63	-19.6 units on a scale Standard Deviation 24.05	-24.2 units on a scale Standard Deviation 31.25
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-15.8 units on a scale Standard Deviation 30.76	-18.6 units on a scale Standard Deviation 21.01	-20.4 units on a scale Standard Deviation 23.40	-24.6 units on a scale Standard Deviation 29.17
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-16.9 units on a scale Standard Deviation 27.20	-20.3 units on a scale Standard Deviation 20.23	-20.2 units on a scale Standard Deviation 23.05	-25.0 units on a scale Standard Deviation 29.55
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-18.5 units on a scale Standard Deviation 28.84	-19.6 units on a scale Standard Deviation 22.90	-20.3 units on a scale Standard Deviation 20.80	-24.8 units on a scale Standard Deviation 29.19
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-20.0 units on a scale Standard Deviation 29.52	-18.0 units on a scale Standard Deviation 23.09	-20.3 units on a scale Standard Deviation 21.95	-25.2 units on a scale Standard Deviation 27.24
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-21.3 units on a scale Standard Deviation 28.76	-19.0 units on a scale Standard Deviation 21.14	-20.8 units on a scale Standard Deviation 23.05	-26.3 units on a scale Standard Deviation 27.92
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-20.1 units on a scale Standard Deviation 27.01	-19.1 units on a scale Standard Deviation 23.63	-19.9 units on a scale Standard Deviation 24.04	-24.5 units on a scale Standard Deviation 27.89
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-22.9 units on a scale Standard Deviation 28.89	-19.5 units on a scale Standard Deviation 25.09	-18.6 units on a scale Standard Deviation 24.69	-26.9 units on a scale Standard Deviation 28.56
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-21.7 units on a scale Standard Deviation 31.19	-19.0 units on a scale Standard Deviation 24.98	-18.6 units on a scale Standard Deviation 25.14	-26.4 units on a scale Standard Deviation 28.61
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 76	—	—	—	—	-21.3 units on a scale Standard Deviation 29.79	-20.9 units on a scale Standard Deviation 24.88	-20.3 units on a scale Standard Deviation 25.11	-26.2 units on a scale Standard Deviation 28.19
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 80	—	—	—	—	-21.0 units on a scale Standard Deviation 30.98	-20.4 units on a scale Standard Deviation 24.23	-19.2 units on a scale Standard Deviation 23.56	-27.3 units on a scale Standard Deviation 27.01
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF Change at Week 84	—	—	—	—	-21.1 units on a scale Standard Deviation 31.62	-19.6 units on a scale Standard Deviation 24.67	-19.6 units on a scale Standard Deviation 22.45	-27.0 units on a scale Standard Deviation 28.96

SECONDARY outcome

Timeframe: Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.

The Physician's Global Assessment of Disease Activity was recorded using the 100 mm horizontal VAS. Physician rated participant's RA disease activity on a scale ranged from 0-100 mm, where 0 indicated no disease activity (no arthritis) and 100 represented maximum disease activity (maximum arthritis). Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-25.8 units on a scale Standard Deviation 28.22	-19.8 units on a scale Standard Deviation 22.76	-27.6 units on a scale Standard Deviation 19.34	-29.2 units on a scale Standard Deviation 28.51
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Baseline	54.3 units on a scale Standard Deviation 19.07	53.1 units on a scale Standard Deviation 21.88	55.2 units on a scale Standard Deviation 17.27	54.2 units on a scale Standard Deviation 22.02	53.7 units on a scale Standard Deviation 19.17	52.0 units on a scale Standard Deviation 22.20	54.2 units on a scale Standard Deviation 17.30	53.9 units on a scale Standard Deviation 21.28
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 2	-10.1 units on a scale Standard Deviation 15.95	-9.5 units on a scale Standard Deviation 16.32	-11.1 units on a scale Standard Deviation 15.59	-7.9 units on a scale Standard Deviation 16.61	-10.4 units on a scale Standard Deviation 14.73	-7.3 units on a scale Standard Deviation 14.59	-10.3 units on a scale Standard Deviation 15.78	-8.1 units on a scale Standard Deviation 17.63
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 4	-8.4 units on a scale Standard Deviation 16.83	-7.6 units on a scale Standard Deviation 14.11	-15.2 units on a scale Standard Deviation 16.36	-13.2 units on a scale Standard Deviation 20.76	-9.9 units on a scale Standard Deviation 15.99	-6.7 units on a scale Standard Deviation 13.23	-15.0 units on a scale Standard Deviation 16.68	-13.8 units on a scale Standard Deviation 21.74
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 8	-13.6 units on a scale Standard Deviation 21.08	-11.3 units on a scale Standard Deviation 16.87	-16.6 units on a scale Standard Deviation 20.75	-16.1 units on a scale Standard Deviation 21.51	-15.5 units on a scale Standard Deviation 17.70	-9.3 units on a scale Standard Deviation 15.25	-16.7 units on a scale Standard Deviation 21.00	-19.0 units on a scale Standard Deviation 21.63
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 12	-14.9 units on a scale Standard Deviation 24.14	-16.9 units on a scale Standard Deviation 24.74	-21.6 units on a scale Standard Deviation 18.54	-18.1 units on a scale Standard Deviation 26.27	-17.1 units on a scale Standard Deviation 21.36	-16.8 units on a scale Standard Deviation 25.04	-22.3 units on a scale Standard Deviation 17.53	-19.5 units on a scale Standard Deviation 26.63
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 16	-16.1 units on a scale Standard Deviation 23.49	-19.3 units on a scale Standard Deviation 20.88	-23.1 units on a scale Standard Deviation 20.21	-19.3 units on a scale Standard Deviation 25.83	-19.1 units on a scale Standard Deviation 21.49	-19.3 units on a scale Standard Deviation 20.91	-23.6 units on a scale Standard Deviation 20.00	-23.7 units on a scale Standard Deviation 23.80
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-25.2 units on a scale Standard Deviation 26.39	-22.7 units on a scale Standard Deviation 25.52	-27.8 units on a scale Standard Deviation 16.77	-27.0 units on a scale Standard Deviation 27.64
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 20	-15.3 units on a scale Standard Deviation 25.97	-20.0 units on a scale Standard Deviation 21.27	-22.7 units on a scale Standard Deviation 20.32	-18.9 units on a scale Standard Deviation 28.39	-18.8 units on a scale Standard Deviation 24.20	-20.9 units on a scale Standard Deviation 21.65	-23.3 units on a scale Standard Deviation 19.81	-23.1 units on a scale Standard Deviation 27.08
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 24	-15.5 units on a scale Standard Deviation 26.23	-17.8 units on a scale Standard Deviation 24.33	-24.6 units on a scale Standard Deviation 21.38	-20.8 units on a scale Standard Deviation 27.39	-19.0 units on a scale Standard Deviation 24.49	-18.4 units on a scale Standard Deviation 24.96	-25.4 units on a scale Standard Deviation 20.91	-25.7 units on a scale Standard Deviation 25.19
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-24.4 units on a scale Standard Deviation 22.28	-20.1 units on a scale Standard Deviation 24.68	-28.1 units on a scale Standard Deviation 19.69	-27.4 units on a scale Standard Deviation 26.36
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-25.9 units on a scale Standard Deviation 25.28	-21.7 units on a scale Standard Deviation 26.24	-24.4 units on a scale Standard Deviation 21.13	-25.9 units on a scale Standard Deviation 26.01
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-23.9 units on a scale Standard Deviation 25.96	-19.3 units on a scale Standard Deviation 23.02	-25.3 units on a scale Standard Deviation 20.46	-29.2 units on a scale Standard Deviation 27.19
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-27.3 units on a scale Standard Deviation 29.35	-21.6 units on a scale Standard Deviation 25.58	-27.8 units on a scale Standard Deviation 20.44	-26.9 units on a scale Standard Deviation 29.34
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-23.3 units on a scale Standard Deviation 28.22	-19.9 units on a scale Standard Deviation 24.81	-26.7 units on a scale Standard Deviation 20.55	-26.8 units on a scale Standard Deviation 28.30
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-23.6 units on a scale Standard Deviation 25.87	-20.8 units on a scale Standard Deviation 24.91	-26.8 units on a scale Standard Deviation 19.72	-28.2 units on a scale Standard Deviation 26.27
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-23.9 units on a scale Standard Deviation 28.72	-21.1 units on a scale Standard Deviation 23.93	-27.0 units on a scale Standard Deviation 21.24	-29.7 units on a scale Standard Deviation 26.70
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-26.4 units on a scale Standard Deviation 28.15	-20.1 units on a scale Standard Deviation 22.32	-24.9 units on a scale Standard Deviation 21.16	-29.4 units on a scale Standard Deviation 25.93
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-27.9 units on a scale Standard Deviation 27.73	-21.6 units on a scale Standard Deviation 26.92	-27.4 units on a scale Standard Deviation 21.10	-30.3 units on a scale Standard Deviation 27.03
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-25.0 units on a scale Standard Deviation 28.10	-20.2 units on a scale Standard Deviation 22.55	-27.1 units on a scale Standard Deviation 22.45	-29.0 units on a scale Standard Deviation 25.74
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 76	—	—	—	—	-23.5 units on a scale Standard Deviation 28.17	-22.4 units on a scale Standard Deviation 22.89	-27.6 units on a scale Standard Deviation 21.89	-31.2 units on a scale Standard Deviation 26.22
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 80	—	—	—	—	-24.0 units on a scale Standard Deviation 28.33	-24.9 units on a scale Standard Deviation 26.05	-26.9 units on a scale Standard Deviation 21.29	-31.5 units on a scale Standard Deviation 25.95
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF Change at Week 84	—	—	—	—	-25.9 units on a scale Standard Deviation 28.47	-21.8 units on a scale Standard Deviation 24.09	-27.3 units on a scale Standard Deviation 20.49	-30.1 units on a scale Standard Deviation 25.70

SECONDARY outcome

Timeframe: Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.

The degree of disability was self-evaluated by the participant using the HAQ-DI. The assessment was made based on the activities capable without any aids or devices. The 20-question instrument assessed the degree of difficulty a person had in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0, indicated no difficulty, to 3, indicated inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 20	0.02 units on a scale Standard Deviation 0.519	-0.10 units on a scale Standard Deviation 0.285	-0.17 units on a scale Standard Deviation 0.335	-0.14 units on a scale Standard Deviation 0.435	-0.03 units on a scale Standard Deviation 0.485	-0.09 units on a scale Standard Deviation 0.285	-0.17 units on a scale Standard Deviation 0.337	-0.16 units on a scale Standard Deviation 0.461
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 76	—	—	—	—	-0.16 units on a scale Standard Deviation 0.557	-0.11 units on a scale Standard Deviation 0.309	-0.18 units on a scale Standard Deviation 0.475	-0.26 units on a scale Standard Deviation 0.602
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Baseline	0.77 units on a scale Standard Deviation 0.526	0.73 units on a scale Standard Deviation 0.527	0.75 units on a scale Standard Deviation 0.602	0.80 units on a scale Standard Deviation 0.611	0.75 units on a scale Standard Deviation 0.519	0.72 units on a scale Standard Deviation 0.541	0.74 units on a scale Standard Deviation 0.618	0.71 units on a scale Standard Deviation 0.543
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 2	0.00 units on a scale Standard Deviation 0.281	-0.01 units on a scale Standard Deviation 0.236	-0.06 units on a scale Standard Deviation 0.295	-0.06 units on a scale Standard Deviation 0.301	-0.03 units on a scale Standard Deviation 0.223	0.00 units on a scale Standard Deviation 0.240	-0.05 units on a scale Standard Deviation 0.297	-0.05 units on a scale Standard Deviation 0.306
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 4	0.02 units on a scale Standard Deviation 0.352	0.01 units on a scale Standard Deviation 0.277	-0.07 units on a scale Standard Deviation 0.299	-0.10 units on a scale Standard Deviation 0.303	-0.02 units on a scale Standard Deviation 0.265	0.03 units on a scale Standard Deviation 0.281	-0.06 units on a scale Standard Deviation 0.301	-0.12 units on a scale Standard Deviation 0.304
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 8	0.00 units on a scale Standard Deviation 0.432	-0.03 units on a scale Standard Deviation 0.298	-0.10 units on a scale Standard Deviation 0.323	-0.12 units on a scale Standard Deviation 0.329	-0.03 units on a scale Standard Deviation 0.379	-0.03 units on a scale Standard Deviation 0.296	-0.08 units on a scale Standard Deviation 0.319	-0.13 units on a scale Standard Deviation 0.350
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 12	0.01 units on a scale Standard Deviation 0.493	-0.06 units on a scale Standard Deviation 0.356	-0.13 units on a scale Standard Deviation 0.321	-0.14 units on a scale Standard Deviation 0.402	-0.02 units on a scale Standard Deviation 0.463	-0.04 units on a scale Standard Deviation 0.351	-0.11 units on a scale Standard Deviation 0.321	-0.16 units on a scale Standard Deviation 0.422
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 16	-0.03 units on a scale Standard Deviation 0.469	-0.08 units on a scale Standard Deviation 0.330	-0.19 units on a scale Standard Deviation 0.330	-0.13 units on a scale Standard Deviation 0.411	-0.06 units on a scale Standard Deviation 0.434	-0.06 units on a scale Standard Deviation 0.315	-0.18 units on a scale Standard Deviation 0.332	-0.15 units on a scale Standard Deviation 0.433
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 24	-0.02 units on a scale Standard Deviation 0.494	-0.09 units on a scale Standard Deviation 0.300	-0.17 units on a scale Standard Deviation 0.337	-0.17 units on a scale Standard Deviation 0.446	-0.07 units on a scale Standard Deviation 0.450	-0.08 units on a scale Standard Deviation 0.300	-0.16 units on a scale Standard Deviation 0.339	-0.20 units on a scale Standard Deviation 0.470
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-0.07 units on a scale Standard Deviation 0.523	-0.09 units on a scale Standard Deviation 0.278	-0.21 units on a scale Standard Deviation 0.407	-0.23 units on a scale Standard Deviation 0.479
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-0.11 units on a scale Standard Deviation 0.544	-0.13 units on a scale Standard Deviation 0.314	-0.18 units on a scale Standard Deviation 0.392	-0.10 units on a scale Standard Deviation 0.670
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-0.05 units on a scale Standard Deviation 0.547	-0.06 units on a scale Standard Deviation 0.396	-0.20 units on a scale Standard Deviation 0.381	-0.17 units on a scale Standard Deviation 0.614
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-0.05 units on a scale Standard Deviation 0.531	-0.08 units on a scale Standard Deviation 0.337	-0.17 units on a scale Standard Deviation 0.318	-0.19 units on a scale Standard Deviation 0.594
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-0.10 units on a scale Standard Deviation 0.544	-0.11 units on a scale Standard Deviation 0.380	-0.19 units on a scale Standard Deviation 0.415	-0.19 units on a scale Standard Deviation 0.561
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-0.08 units on a scale Standard Deviation 0.546	-0.06 units on a scale Standard Deviation 0.366	-0.20 units on a scale Standard Deviation 0.434	-0.20 units on a scale Standard Deviation 0.592
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-0.06 units on a scale Standard Deviation 0.535	-0.04 units on a scale Standard Deviation 0.318	-0.22 units on a scale Standard Deviation 0.385	-0.19 units on a scale Standard Deviation 0.549
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-0.09 units on a scale Standard Deviation 0.525	-0.06 units on a scale Standard Deviation 0.303	-0.20 units on a scale Standard Deviation 0.425	-0.20 units on a scale Standard Deviation 0.539
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-0.10 units on a scale Standard Deviation 0.551	-0.09 units on a scale Standard Deviation 0.297	-0.19 units on a scale Standard Deviation 0.422	-0.24 units on a scale Standard Deviation 0.567
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-0.09 units on a scale Standard Deviation 0.518	-0.06 units on a scale Standard Deviation 0.366	-0.13 units on a scale Standard Deviation 0.457	-0.25 units on a scale Standard Deviation 0.591
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-0.13 units on a scale Standard Deviation 0.559	-0.09 units on a scale Standard Deviation 0.356	-0.16 units on a scale Standard Deviation 0.508	-0.24 units on a scale Standard Deviation 0.597
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-0.17 units on a scale Standard Deviation 0.542	-0.06 units on a scale Standard Deviation 0.357	-0.19 units on a scale Standard Deviation 0.500	-0.23 units on a scale Standard Deviation 0.596
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 80	—	—	—	—	-0.11 units on a scale Standard Deviation 0.555	-0.12 units on a scale Standard Deviation 0.325	-0.16 units on a scale Standard Deviation 0.514	-0.25 units on a scale Standard Deviation 0.579
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF Change at Week 84	—	—	—	—	-0.15 units on a scale Standard Deviation 0.567	-0.08 units on a scale Standard Deviation 0.332	-0.19 units on a scale Standard Deviation 0.467	-0.25 units on a scale Standard Deviation 0.586

SECONDARY outcome

Timeframe: Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.

CRP of each participants was measured as a part of blood biochemical tests. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Baseline	1.50 milligram per deciliter (mg/dL) Standard Deviation 1.633	1.44 milligram per deciliter (mg/dL) Standard Deviation 1.868	1.08 milligram per deciliter (mg/dL) Standard Deviation 0.840	1.24 milligram per deciliter (mg/dL) Standard Deviation 1.634	1.42 milligram per deciliter (mg/dL) Standard Deviation 1.682	1.41 milligram per deciliter (mg/dL) Standard Deviation 1.901	1.04 milligram per deciliter (mg/dL) Standard Deviation 0.843	1.07 milligram per deciliter (mg/dL) Standard Deviation 1.291
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 2	-0.09 milligram per deciliter (mg/dL) Standard Deviation 0.909	-0.28 milligram per deciliter (mg/dL) Standard Deviation 1.148	0.08 milligram per deciliter (mg/dL) Standard Deviation 0.707	0.07 milligram per deciliter (mg/dL) Standard Deviation 0.777	-0.16 milligram per deciliter (mg/dL) Standard Deviation 0.930	-0.32 milligram per deciliter (mg/dL) Standard Deviation 1.176	0.08 milligram per deciliter (mg/dL) Standard Deviation 0.715	0.12 milligram per deciliter (mg/dL) Standard Deviation 0.769
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 4	0.06 milligram per deciliter (mg/dL) Standard Deviation 1.235	0.20 milligram per deciliter (mg/dL) Standard Deviation 1.279	0.04 milligram per deciliter (mg/dL) Standard Deviation 0.707	0.33 milligram per deciliter (mg/dL) Standard Deviation 1.383	-0.14 milligram per deciliter (mg/dL) Standard Deviation 1.134	0.15 milligram per deciliter (mg/dL) Standard Deviation 1.268	0.03 milligram per deciliter (mg/dL) Standard Deviation 0.694	0.28 milligram per deciliter (mg/dL) Standard Deviation 1.443
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 8	0.21 milligram per deciliter (mg/dL) Standard Deviation 1.192	0.12 milligram per deciliter (mg/dL) Standard Deviation 1.750	0.29 milligram per deciliter (mg/dL) Standard Deviation 1.407	-0.03 milligram per deciliter (mg/dL) Standard Deviation 1.343	0.04 milligram per deciliter (mg/dL) Standard Deviation 1.103	0.08 milligram per deciliter (mg/dL) Standard Deviation 1.787	0.28 milligram per deciliter (mg/dL) Standard Deviation 1.452	-0.15 milligram per deciliter (mg/dL) Standard Deviation 1.392
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 12	0.15 milligram per deciliter (mg/dL) Standard Deviation 1.503	-0.23 milligram per deciliter (mg/dL) Standard Deviation 1.429	-0.06 milligram per deciliter (mg/dL) Standard Deviation 1.263	-0.05 milligram per deciliter (mg/dL) Standard Deviation 1.403	0.01 milligram per deciliter (mg/dL) Standard Deviation 1.485	-0.26 milligram per deciliter (mg/dL) Standard Deviation 1.481	-0.07 milligram per deciliter (mg/dL) Standard Deviation 1.309	-0.24 milligram per deciliter (mg/dL) Standard Deviation 1.314
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 16	0.17 milligram per deciliter (mg/dL) Standard Deviation 1.429	-0.26 milligram per deciliter (mg/dL) Standard Deviation 1.626	-0.11 milligram per deciliter (mg/dL) Standard Deviation 1.214	0.09 milligram per deciliter (mg/dL) Standard Deviation 1.737	0.00 milligram per deciliter (mg/dL) Standard Deviation 1.412	-0.29 milligram per deciliter (mg/dL) Standard Deviation 1.684	-0.10 milligram per deciliter (mg/dL) Standard Deviation 1.249	-0.08 milligram per deciliter (mg/dL) Standard Deviation 1.713
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 20	0.24 milligram per deciliter (mg/dL) Standard Deviation 1.686	-0.17 milligram per deciliter (mg/dL) Standard Deviation 1.683	-0.18 milligram per deciliter (mg/dL) Standard Deviation 1.071	0.01 milligram per deciliter (mg/dL) Standard Deviation 1.332	0.00 milligram per deciliter (mg/dL) Standard Deviation 1.652	-0.25 milligram per deciliter (mg/dL) Standard Deviation 1.712	-0.23 milligram per deciliter (mg/dL) Standard Deviation 1.060	-0.14 milligram per deciliter (mg/dL) Standard Deviation 1.154
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 24	0.39 milligram per deciliter (mg/dL) Standard Deviation 2.063	-0.26 milligram per deciliter (mg/dL) Standard Deviation 1.887	0.01 milligram per deciliter (mg/dL) Standard Deviation 1.155	0.38 milligram per deciliter (mg/dL) Standard Deviation 2.220	0.18 milligram per deciliter (mg/dL) Standard Deviation 2.106	-0.35 milligram per deciliter (mg/dL) Standard Deviation 1.924	-0.03 milligram per deciliter (mg/dL) Standard Deviation 1.161	0.30 milligram per deciliter (mg/dL) Standard Deviation 2.269
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-0.24 milligram per deciliter (mg/dL) Standard Deviation 1.792	-0.34 milligram per deciliter (mg/dL) Standard Deviation 1.603	-0.21 milligram per deciliter (mg/dL) Standard Deviation 0.997	-0.19 milligram per deciliter (mg/dL) Standard Deviation 1.677
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-0.10 milligram per deciliter (mg/dL) Standard Deviation 2.067	-0.32 milligram per deciliter (mg/dL) Standard Deviation 1.617	0.13 milligram per deciliter (mg/dL) Standard Deviation 1.585	-0.35 milligram per deciliter (mg/dL) Standard Deviation 1.371
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-0.10 milligram per deciliter (mg/dL) Standard Deviation 1.839	-0.13 milligram per deciliter (mg/dL) Standard Deviation 2.311	-0.04 milligram per deciliter (mg/dL) Standard Deviation 1.301	-0.24 milligram per deciliter (mg/dL) Standard Deviation 1.691
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-0.17 milligram per deciliter (mg/dL) Standard Deviation 1.852	-0.30 milligram per deciliter (mg/dL) Standard Deviation 1.801	-0.10 milligram per deciliter (mg/dL) Standard Deviation 1.100	-0.25 milligram per deciliter (mg/dL) Standard Deviation 1.539
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-0.10 milligram per deciliter (mg/dL) Standard Deviation 1.939	-0.35 milligram per deciliter (mg/dL) Standard Deviation 1.908	0.26 milligram per deciliter (mg/dL) Standard Deviation 1.798	-0.17 milligram per deciliter (mg/dL) Standard Deviation 1.470
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 48	—	—	—	—	0.14 milligram per deciliter (mg/dL) Standard Deviation 1.910	-0.25 milligram per deciliter (mg/dL) Standard Deviation 2.131	-0.04 milligram per deciliter (mg/dL) Standard Deviation 1.103	-0.32 milligram per deciliter (mg/dL) Standard Deviation 1.416
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 52	—	—	—	—	0.33 milligram per deciliter (mg/dL) Standard Deviation 2.130	-0.23 milligram per deciliter (mg/dL) Standard Deviation 2.288	-0.10 milligram per deciliter (mg/dL) Standard Deviation 1.134	-0.14 milligram per deciliter (mg/dL) Standard Deviation 1.162
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-0.09 milligram per deciliter (mg/dL) Standard Deviation 1.967	-0.44 milligram per deciliter (mg/dL) Standard Deviation 2.001	-0.03 milligram per deciliter (mg/dL) Standard Deviation 1.264	-0.27 milligram per deciliter (mg/dL) Standard Deviation 1.124
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-0.13 milligram per deciliter (mg/dL) Standard Deviation 1.956	-0.14 milligram per deciliter (mg/dL) Standard Deviation 2.375	-0.03 milligram per deciliter (mg/dL) Standard Deviation 1.266	-0.39 milligram per deciliter (mg/dL) Standard Deviation 1.276
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-0.04 milligram per deciliter (mg/dL) Standard Deviation 2.062	-0.34 milligram per deciliter (mg/dL) Standard Deviation 2.115	0.54 milligram per deciliter (mg/dL) Standard Deviation 4.066	-0.40 milligram per deciliter (mg/dL) Standard Deviation 1.307
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-0.26 milligram per deciliter (mg/dL) Standard Deviation 2.207	-0.23 milligram per deciliter (mg/dL) Standard Deviation 2.276	0.13 milligram per deciliter (mg/dL) Standard Deviation 1.662	-0.36 milligram per deciliter (mg/dL) Standard Deviation 1.414
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-0.17 milligram per deciliter (mg/dL) Standard Deviation 2.414	-0.27 milligram per deciliter (mg/dL) Standard Deviation 2.167	0.04 milligram per deciliter (mg/dL) Standard Deviation 1.550	-0.28 milligram per deciliter (mg/dL) Standard Deviation 1.437
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 76	—	—	—	—	-0.09 milligram per deciliter (mg/dL) Standard Deviation 2.382	-0.38 milligram per deciliter (mg/dL) Standard Deviation 2.115	0.07 milligram per deciliter (mg/dL) Standard Deviation 1.593	-0.41 milligram per deciliter (mg/dL) Standard Deviation 1.329
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 80	—	—	—	—	-0.20 milligram per deciliter (mg/dL) Standard Deviation 2.297	-0.32 milligram per deciliter (mg/dL) Standard Deviation 2.065	0.02 milligram per deciliter (mg/dL) Standard Deviation 1.524	-0.40 milligram per deciliter (mg/dL) Standard Deviation 1.260
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF Change at Week 84	—	—	—	—	-0.23 milligram per deciliter (mg/dL) Standard Deviation 2.332	-0.39 milligram per deciliter (mg/dL) Standard Deviation 2.097	0.11 milligram per deciliter (mg/dL) Standard Deviation 1.754	-0.35 milligram per deciliter (mg/dL) Standard Deviation 1.417

SECONDARY outcome

Timeframe: Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80,and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.

ESR were a type of blood test. An ESR was used to monitor the arthritis condition. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-0.6 millimeter per hour (mm/hr) Standard Deviation 19.64	-1.8 millimeter per hour (mm/hr) Standard Deviation 21.69	-2.5 millimeter per hour (mm/hr) Standard Deviation 25.04	-4.9 millimeter per hour (mm/hr) Standard Deviation 20.18
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 12	-0.3 millimeter per hour (mm/hr) Standard Deviation 16.46	-2.9 millimeter per hour (mm/hr) Standard Deviation 15.53	-3.8 millimeter per hour (mm/hr) Standard Deviation 18.39	-3.5 millimeter per hour (mm/hr) Standard Deviation 17.83	-1.5 millimeter per hour (mm/hr) Standard Deviation 15.28	-3.4 millimeter per hour (mm/hr) Standard Deviation 16.00	-4.7 millimeter per hour (mm/hr) Standard Deviation 18.38	-5.7 millimeter per hour (mm/hr) Standard Deviation 17.77
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 16	-1.9 millimeter per hour (mm/hr) Standard Deviation 15.78	-3.3 millimeter per hour (mm/hr) Standard Deviation 18.53	-5.5 millimeter per hour (mm/hr) Standard Deviation 20.68	-2.2 millimeter per hour (mm/hr) Standard Deviation 19.92	-3.6 millimeter per hour (mm/hr) Standard Deviation 14.47	-3.8 millimeter per hour (mm/hr) Standard Deviation 19.14	-6.0 millimeter per hour (mm/hr) Standard Deviation 21.05	-4.7 millimeter per hour (mm/hr) Standard Deviation 20.03
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 20	-0.6 millimeter per hour (mm/hr) Standard Deviation 22.08	-1.3 millimeter per hour (mm/hr) Standard Deviation 18.75	-6.6 millimeter per hour (mm/hr) Standard Deviation 20.32	-4.0 millimeter per hour (mm/hr) Standard Deviation 19.17	-2.3 millimeter per hour (mm/hr) Standard Deviation 21.23	-2.3 millimeter per hour (mm/hr) Standard Deviation 19.00	-8.0 millimeter per hour (mm/hr) Standard Deviation 19.80	-6.8 millimeter per hour (mm/hr) Standard Deviation 18.86
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 24	-0.1 millimeter per hour (mm/hr) Standard Deviation 23.16	0.6 millimeter per hour (mm/hr) Standard Deviation 20.14	-4.0 millimeter per hour (mm/hr) Standard Deviation 21.67	-2.9 millimeter per hour (mm/hr) Standard Deviation 20.41	-1.8 millimeter per hour (mm/hr) Standard Deviation 22.56	-0.3 millimeter per hour (mm/hr) Standard Deviation 20.57	-5.2 millimeter per hour (mm/hr) Standard Deviation 21.47	-5.4 millimeter per hour (mm/hr) Standard Deviation 20.52
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-4.6 millimeter per hour (mm/hr) Standard Deviation 20.04	-4.3 millimeter per hour (mm/hr) Standard Deviation 19.51	-3.4 millimeter per hour (mm/hr) Standard Deviation 23.67	-8.0 millimeter per hour (mm/hr) Standard Deviation 18.76
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-3.4 millimeter per hour (mm/hr) Standard Deviation 21.50	-5.0 millimeter per hour (mm/hr) Standard Deviation 16.34	-3.9 millimeter per hour (mm/hr) Standard Deviation 23.50	-7.4 millimeter per hour (mm/hr) Standard Deviation 20.18
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-4.7 millimeter per hour (mm/hr) Standard Deviation 20.43	-4.5 millimeter per hour (mm/hr) Standard Deviation 20.44	-1.9 millimeter per hour (mm/hr) Standard Deviation 23.56	-4.8 millimeter per hour (mm/hr) Standard Deviation 20.81
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-3.4 millimeter per hour (mm/hr) Standard Deviation 19.46	-3.5 millimeter per hour (mm/hr) Standard Deviation 19.77	-3.1 millimeter per hour (mm/hr) Standard Deviation 24.00	-5.8 millimeter per hour (mm/hr) Standard Deviation 21.58
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-3.2 millimeter per hour (mm/hr) Standard Deviation 20.19	-4.4 millimeter per hour (mm/hr) Standard Deviation 21.73	-3.2 millimeter per hour (mm/hr) Standard Deviation 24.65	-4.8 millimeter per hour (mm/hr) Standard Deviation 22.59
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-2.0 millimeter per hour (mm/hr) Standard Deviation 19.12	-2.0 millimeter per hour (mm/hr) Standard Deviation 20.91	-4.2 millimeter per hour (mm/hr) Standard Deviation 20.41	-5.5 millimeter per hour (mm/hr) Standard Deviation 19.42
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-4.6 millimeter per hour (mm/hr) Standard Deviation 21.59	-4.4 millimeter per hour (mm/hr) Standard Deviation 20.37	-3.9 millimeter per hour (mm/hr) Standard Deviation 23.46	-6.2 millimeter per hour (mm/hr) Standard Deviation 19.83
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-4.9 millimeter per hour (mm/hr) Standard Deviation 22.00	-2.6 millimeter per hour (mm/hr) Standard Deviation 23.13	-3.6 millimeter per hour (mm/hr) Standard Deviation 26.27	-7.6 millimeter per hour (mm/hr) Standard Deviation 19.37
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-4.1 millimeter per hour (mm/hr) Standard Deviation 24.32	-3.2 millimeter per hour (mm/hr) Standard Deviation 22.29	-5.5 millimeter per hour (mm/hr) Standard Deviation 24.06	-8.0 millimeter per hour (mm/hr) Standard Deviation 18.98
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-4.0 millimeter per hour (mm/hr) Standard Deviation 24.77	-3.2 millimeter per hour (mm/hr) Standard Deviation 22.21	-5.9 millimeter per hour (mm/hr) Standard Deviation 22.68	-8.7 millimeter per hour (mm/hr) Standard Deviation 17.98
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-4.5 millimeter per hour (mm/hr) Standard Deviation 27.08	-3.7 millimeter per hour (mm/hr) Standard Deviation 20.94	-4.3 millimeter per hour (mm/hr) Standard Deviation 24.37	-7.8 millimeter per hour (mm/hr) Standard Deviation 20.01
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 76	—	—	—	—	-4.2 millimeter per hour (mm/hr) Standard Deviation 26.28	-4.8 millimeter per hour (mm/hr) Standard Deviation 18.96	-4.4 millimeter per hour (mm/hr) Standard Deviation 22.94	-7.9 millimeter per hour (mm/hr) Standard Deviation 18.92
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 80	—	—	—	—	-5.7 millimeter per hour (mm/hr) Standard Deviation 27.22	-4.6 millimeter per hour (mm/hr) Standard Deviation 19.36	-6.1 millimeter per hour (mm/hr) Standard Deviation 24.45	-9.1 millimeter per hour (mm/hr) Standard Deviation 18.06
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 84	—	—	—	—	-5.9 millimeter per hour (mm/hr) Standard Deviation 25.74	-5.1 millimeter per hour (mm/hr) Standard Deviation 19.08	-3.0 millimeter per hour (mm/hr) Standard Deviation 24.74	-8.1 millimeter per hour (mm/hr) Standard Deviation 18.95
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Baseline	41.6 millimeter per hour (mm/hr) Standard Deviation 26.37	37.9 millimeter per hour (mm/hr) Standard Deviation 16.62	40.8 millimeter per hour (mm/hr) Standard Deviation 20.06	40.1 millimeter per hour (mm/hr) Standard Deviation 20.45	39.6 millimeter per hour (mm/hr) Standard Deviation 26.47	37.6 millimeter per hour (mm/hr) Standard Deviation 17.21	40.0 millimeter per hour (mm/hr) Standard Deviation 19.67	38.3 millimeter per hour (mm/hr) Standard Deviation 16.91
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 2	-3.8 millimeter per hour (mm/hr) Standard Deviation 10.40	1.0 millimeter per hour (mm/hr) Standard Deviation 8.25	-1.9 millimeter per hour (mm/hr) Standard Deviation 7.53	0.7 millimeter per hour (mm/hr) Standard Deviation 10.38	-4.1 millimeter per hour (mm/hr) Standard Deviation 10.49	1.7 millimeter per hour (mm/hr) Standard Deviation 8.00	-2.1 millimeter per hour (mm/hr) Standard Deviation 7.70	0.4 millimeter per hour (mm/hr) Standard Deviation 10.92
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 4	-2.3 millimeter per hour (mm/hr) Standard Deviation 14.51	1.3 millimeter per hour (mm/hr) Standard Deviation 11.79	-2.6 millimeter per hour (mm/hr) Standard Deviation 7.42	-1.1 millimeter per hour (mm/hr) Standard Deviation 13.38	-3.4 millimeter per hour (mm/hr) Standard Deviation 14.07	1.3 millimeter per hour (mm/hr) Standard Deviation 12.22	-2.8 millimeter per hour (mm/hr) Standard Deviation 7.62	-2.2 millimeter per hour (mm/hr) Standard Deviation 13.49
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF Change at Week 8	0.2 millimeter per hour (mm/hr) Standard Deviation 17.72	-0.3 millimeter per hour (mm/hr) Standard Deviation 11.62	-1.8 millimeter per hour (mm/hr) Standard Deviation 14.43	-3.7 millimeter per hour (mm/hr) Standard Deviation 15.09	-1.5 millimeter per hour (mm/hr) Standard Deviation 16.90	-0.5 millimeter per hour (mm/hr) Standard Deviation 11.55	-2.7 millimeter per hour (mm/hr) Standard Deviation 14.19	-5.3 millimeter per hour (mm/hr) Standard Deviation 15.29

SECONDARY outcome

Timeframe: Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.

The DAS28 index was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and ESR value. Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value <2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Baseline	5.709 score on a scale Standard Deviation 0.9161	5.687 score on a scale Standard Deviation 0.9278	5.819 score on a scale Standard Deviation 0.7696	5.984 score on a scale Standard Deviation 0.8865	5.653 score on a scale Standard Deviation 0.9149	5.674 score on a scale Standard Deviation 0.9625	5.775 score on a scale Standard Deviation 0.6980	5.931 score on a scale Standard Deviation 0.8490
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-1.512 score on a scale Standard Deviation 1.3217	-1.457 score on a scale Standard Deviation 1.2777	-1.617 score on a scale Standard Deviation 1.4220	-1.856 score on a scale Standard Deviation 1.5063
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-1.443 score on a scale Standard Deviation 1.3900	-1.336 score on a scale Standard Deviation 1.3160	-1.718 score on a scale Standard Deviation 1.2962	-1.994 score on a scale Standard Deviation 1.5330
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-1.438 score on a scale Standard Deviation 1.4786	-1.447 score on a scale Standard Deviation 1.3270	-1.734 score on a scale Standard Deviation 1.2812	-2.004 score on a scale Standard Deviation 1.4325
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-1.387 score on a scale Standard Deviation 1.4577	-1.364 score on a scale Standard Deviation 1.2433	-1.682 score on a scale Standard Deviation 1.1280	-1.956 score on a scale Standard Deviation 1.4547
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-1.409 score on a scale Standard Deviation 1.3896	-1.362 score on a scale Standard Deviation 1.3332	-1.672 score on a scale Standard Deviation 1.1859	-1.947 score on a scale Standard Deviation 1.5247
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 2	-0.520 score on a scale Standard Deviation 0.7531	-0.402 score on a scale Standard Deviation 0.5058	-0.554 score on a scale Standard Deviation 0.6165	-0.420 score on a scale Standard Deviation 0.6906	-0.580 score on a scale Standard Deviation 0.7398	-0.392 score on a scale Standard Deviation 0.4917	-0.541 score on a scale Standard Deviation 0.6199	-0.436 score on a scale Standard Deviation 0.7121
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 4	-0.571 score on a scale Standard Deviation 0.8416	-0.434 score on a scale Standard Deviation 0.6825	-0.702 score on a scale Standard Deviation 0.6534	-0.833 score on a scale Standard Deviation 1.0092	-0.641 score on a scale Standard Deviation 0.8217	-0.423 score on a scale Standard Deviation 0.6709	-0.710 score on a scale Standard Deviation 0.6435	-0.896 score on a scale Standard Deviation 1.0426
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 8	-0.674 score on a scale Standard Deviation 1.1682	-0.642 score on a scale Standard Deviation 0.8081	-0.919 score on a scale Standard Deviation 0.8813	-1.217 score on a scale Standard Deviation 1.1963	-0.839 score on a scale Standard Deviation 1.0703	-0.653 score on a scale Standard Deviation 0.7871	-0.947 score on a scale Standard Deviation 0.8681	-1.306 score on a scale Standard Deviation 1.2425
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 12	-0.763 score on a scale Standard Deviation 1.2561	-1.007 score on a scale Standard Deviation 1.0644	-1.237 score on a scale Standard Deviation 1.0536	-1.277 score on a scale Standard Deviation 1.4323	-0.934 score on a scale Standard Deviation 1.1527	-1.053 score on a scale Standard Deviation 1.0693	-1.302 score on a scale Standard Deviation 0.9895	-1.443 score on a scale Standard Deviation 1.4777
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 16	-1.022 score on a scale Standard Deviation 1.3026	-1.134 score on a scale Standard Deviation 1.1573	-1.391 score on a scale Standard Deviation 1.0674	-1.349 score on a scale Standard Deviation 1.4847	-1.242 score on a scale Standard Deviation 1.1588	-1.195 score on a scale Standard Deviation 1.1625	-1.445 score on a scale Standard Deviation 1.0294	-1.581 score on a scale Standard Deviation 1.4581
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-1.367 score on a scale Standard Deviation 1.3085	-1.391 score on a scale Standard Deviation 1.2689	-1.727 score on a scale Standard Deviation 1.2501	-2.063 score on a scale Standard Deviation 1.5432
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-1.516 score on a scale Standard Deviation 1.4242	-1.398 score on a scale Standard Deviation 1.2493	-1.678 score on a scale Standard Deviation 1.2286	-2.122 score on a scale Standard Deviation 1.4580
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-1.528 score on a scale Standard Deviation 1.4876	-1.579 score on a scale Standard Deviation 1.3403	-1.764 score on a scale Standard Deviation 1.4278	-2.145 score on a scale Standard Deviation 1.4990
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-1.483 score on a scale Standard Deviation 1.4218	-1.538 score on a scale Standard Deviation 1.2862	-1.652 score on a scale Standard Deviation 1.3363	-2.188 score on a scale Standard Deviation 1.4525
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-1.598 score on a scale Standard Deviation 1.4828	-1.411 score on a scale Standard Deviation 1.3355	-1.729 score on a scale Standard Deviation 1.4047	-2.221 score on a scale Standard Deviation 1.4155
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-1.528 score on a scale Standard Deviation 1.5740	-1.402 score on a scale Standard Deviation 1.2321	-1.742 score on a scale Standard Deviation 1.3978	-2.100 score on a scale Standard Deviation 1.4930
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 76	—	—	—	—	-1.547 score on a scale Standard Deviation 1.6002	-1.458 score on a scale Standard Deviation 1.1877	-1.833 score on a scale Standard Deviation 1.3346	-2.133 score on a scale Standard Deviation 1.3671
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 80	—	—	—	—	-1.580 score on a scale Standard Deviation 1.6735	-1.544 score on a scale Standard Deviation 1.2228	-1.773 score on a scale Standard Deviation 1.2908	-2.194 score on a scale Standard Deviation 1.4738
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 84	—	—	—	—	-1.599 score on a scale Standard Deviation 1.5656	-1.584 score on a scale Standard Deviation 1.3414	-1.812 score on a scale Standard Deviation 1.3174	-2.206 score on a scale Standard Deviation 1.5263
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 20	-0.977 score on a scale Standard Deviation 1.3914	-1.156 score on a scale Standard Deviation 1.0949	-1.449 score on a scale Standard Deviation 1.2393	-1.525 score on a scale Standard Deviation 1.4998	-1.215 score on a scale Standard Deviation 1.2400	-1.226 score on a scale Standard Deviation 1.0921	-1.524 score on a scale Standard Deviation 1.1984	-1.787 score on a scale Standard Deviation 1.4405
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 24	-0.950 score on a scale Standard Deviation 1.4587	-1.144 score on a scale Standard Deviation 1.2704	-1.470 score on a scale Standard Deviation 1.1853	-1.536 score on a scale Standard Deviation 1.5340	-1.185 score on a scale Standard Deviation 1.3317	-1.214 score on a scale Standard Deviation 1.2817	-1.546 score on a scale Standard Deviation 1.1363	-1.815 score on a scale Standard Deviation 1.4668
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-1.452 score on a scale Standard Deviation 1.3306	-1.397 score on a scale Standard Deviation 1.3890	-1.652 score on a scale Standard Deviation 1.2452	-1.913 score on a scale Standard Deviation 1.4510

SECONDARY outcome

Timeframe: Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.

The DAS28 index was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value <2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Baseline	5.039 score on a scale Standard Deviation 0.8789	4.993 score on a scale Standard Deviation 1.0096	5.079 score on a scale Standard Deviation 0.7290	5.202 score on a scale Standard Deviation 0.9283	4.997 score on a scale Standard Deviation 0.8561	4.978 score on a scale Standard Deviation 1.0458	5.034 score on a scale Standard Deviation 0.6676	5.138 score on a scale Standard Deviation 0.8998
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 12	-0.692 score on a scale Standard Deviation 1.2057	-1.028 score on a scale Standard Deviation 1.0399	-1.206 score on a scale Standard Deviation 1.0564	-1.164 score on a scale Standard Deviation 1.3302	-0.855 score on a scale Standard Deviation 1.0981	-1.071 score on a scale Standard Deviation 1.0433	-1.260 score on a scale Standard Deviation 1.0062	-1.321 score on a scale Standard Deviation 1.3768
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 20	-0.889 score on a scale Standard Deviation 1.3450	-1.186 score on a scale Standard Deviation 1.0136	-1.397 score on a scale Standard Deviation 1.2380	-1.437 score on a scale Standard Deviation 1.4440	-1.133 score on a scale Standard Deviation 1.1959	-1.264 score on a scale Standard Deviation 1.0004	-1.461 score on a scale Standard Deviation 1.2066	-1.692 score on a scale Standard Deviation 1.3754
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 24	-0.825 score on a scale Standard Deviation 1.3502	-1.212 score on a scale Standard Deviation 1.1955	-1.449 score on a scale Standard Deviation 1.1679	-1.400 score on a scale Standard Deviation 1.4462	-1.058 score on a scale Standard Deviation 1.2175	-1.292 score on a scale Standard Deviation 1.1959	-1.518 score on a scale Standard Deviation 1.1251	-1.666 score on a scale Standard Deviation 1.3715
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-1.363 score on a scale Standard Deviation 1.2248	-1.386 score on a scale Standard Deviation 1.2327	-1.645 score on a scale Standard Deviation 1.2490	-1.770 score on a scale Standard Deviation 1.3779
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-1.438 score on a scale Standard Deviation 1.2821	-1.461 score on a scale Standard Deviation 1.1617	-1.545 score on a scale Standard Deviation 1.4075	-1.724 score on a scale Standard Deviation 1.4062
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-1.319 score on a scale Standard Deviation 1.2935	-1.329 score on a scale Standard Deviation 1.2331	-1.729 score on a scale Standard Deviation 1.2139	-1.910 score on a scale Standard Deviation 1.4317
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-1.343 score on a scale Standard Deviation 1.3170	-1.359 score on a scale Standard Deviation 1.1999	-1.688 score on a scale Standard Deviation 1.0828	-1.835 score on a scale Standard Deviation 1.4415
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 16	-0.913 score on a scale Standard Deviation 1.2429	-1.160 score on a scale Standard Deviation 1.0453	-1.339 score on a scale Standard Deviation 1.0190	-1.250 score on a scale Standard Deviation 1.4208	-1.125 score on a scale Standard Deviation 1.1056	-1.222 score on a scale Standard Deviation 1.0420	-1.385 score on a scale Standard Deviation 0.9817	-1.473 score on a scale Standard Deviation 1.3859
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-1.286 score on a scale Standard Deviation 1.2637	-1.334 score on a scale Standard Deviation 1.1039	-1.702 score on a scale Standard Deviation 1.2073	-1.915 score on a scale Standard Deviation 1.5062
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-1.338 score on a scale Standard Deviation 1.4080	-1.475 score on a scale Standard Deviation 1.2492	-1.658 score on a scale Standard Deviation 1.1945	-1.904 score on a scale Standard Deviation 1.3723
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-1.293 score on a scale Standard Deviation 1.4043	-1.407 score on a scale Standard Deviation 1.1550	-1.660 score on a scale Standard Deviation 1.1057	-1.815 score on a scale Standard Deviation 1.2919
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-1.425 score on a scale Standard Deviation 1.3826	-1.438 score on a scale Standard Deviation 1.1264	-1.603 score on a scale Standard Deviation 1.2139	-1.999 score on a scale Standard Deviation 1.3047
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-1.392 score on a scale Standard Deviation 1.4082	-1.557 score on a scale Standard Deviation 1.1507	-1.697 score on a scale Standard Deviation 1.3250	-2.015 score on a scale Standard Deviation 1.3216
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-1.380 score on a scale Standard Deviation 1.3475	-1.530 score on a scale Standard Deviation 1.1474	-1.579 score on a scale Standard Deviation 1.2837	-2.039 score on a scale Standard Deviation 1.2069
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-1.520 score on a scale Standard Deviation 1.4072	-1.414 score on a scale Standard Deviation 1.2456	-1.627 score on a scale Standard Deviation 1.3523	-2.092 score on a scale Standard Deviation 1.2697
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-1.434 score on a scale Standard Deviation 1.4852	-1.398 score on a scale Standard Deviation 1.1240	-1.698 score on a scale Standard Deviation 1.2813	-1.946 score on a scale Standard Deviation 1.3801
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 76	—	—	—	—	-1.445 score on a scale Standard Deviation 1.5266	-1.489 score on a scale Standard Deviation 1.1022	-1.783 score on a scale Standard Deviation 1.2366	-2.029 score on a scale Standard Deviation 1.2583
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 80	—	—	—	—	-1.438 score on a scale Standard Deviation 1.5290	-1.544 score on a scale Standard Deviation 1.1475	-1.688 score on a scale Standard Deviation 1.1779	-2.069 score on a scale Standard Deviation 1.3821
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 84	—	—	—	—	-1.524 score on a scale Standard Deviation 1.5688	-1.596 score on a scale Standard Deviation 1.2642	-1.750 score on a scale Standard Deviation 1.2376	-2.090 score on a scale Standard Deviation 1.4318
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 2	-0.474 score on a scale Standard Deviation 0.7500	-0.464 score on a scale Standard Deviation 0.5214	-0.531 score on a scale Standard Deviation 0.6404	-0.430 score on a scale Standard Deviation 0.7393	-0.534 score on a scale Standard Deviation 0.7370	-0.459 score on a scale Standard Deviation 0.5043	-0.514 score on a scale Standard Deviation 0.6403	-0.433 score on a scale Standard Deviation 0.7731
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 4	-0.514 score on a scale Standard Deviation 0.8858	-0.407 score on a scale Standard Deviation 0.6521	-0.675 score on a scale Standard Deviation 0.6705	-0.704 score on a scale Standard Deviation 0.9959	-0.591 score on a scale Standard Deviation 0.8735	-0.391 score on a scale Standard Deviation 0.6202	-0.678 score on a scale Standard Deviation 0.6539	-0.747 score on a scale Standard Deviation 1.0501
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF Change at Week 8	-0.607 score on a scale Standard Deviation 1.0640	-0.679 score on a scale Standard Deviation 0.8212	-0.885 score on a scale Standard Deviation 0.8535	-1.059 score on a scale Standard Deviation 1.1604	-0.767 score on a scale Standard Deviation 0.9529	-0.684 score on a scale Standard Deviation 0.7985	-0.905 score on a scale Standard Deviation 0.8341	-1.136 score on a scale Standard Deviation 1.2236

SECONDARY outcome

Timeframe: Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.

The SDAI was calculated from tender joint counts of 28, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score, and CRP value. Total score ranged between 0-86. SDAI score of 26 or above = high disease activity, a value between 11 and 26 = moderate disease activity and value less than or equal to (<=) 11 = low disease activity, value <=33 = disease remission. Higher scores indicated higher disease activity. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 8	-7.241 score on a scale Standard Deviation 12.4374	-7.636 score on a scale Standard Deviation 9.0091	-9.531 score on a scale Standard Deviation 9.5254	-12.839 score on a scale Standard Deviation 13.1334	-9.323 score on a scale Standard Deviation 9.2809	-7.627 score on a scale Standard Deviation 8.9115	-9.668 score on a scale Standard Deviation 9.4114	-13.926 score on a scale Standard Deviation 13.7928
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-13.996 score on a scale Standard Deviation 12.0029	-14.858 score on a scale Standard Deviation 12.5133	-16.818 score on a scale Standard Deviation 11.9239	-18.889 score on a scale Standard Deviation 13.9459
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-14.166 score on a scale Standard Deviation 13.8122	-15.538 score on a scale Standard Deviation 11.5883	-16.628 score on a scale Standard Deviation 12.4186	-20.746 score on a scale Standard Deviation 13.3296
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-15.549 score on a scale Standard Deviation 14.3214	-14.185 score on a scale Standard Deviation 13.1359	-16.294 score on a scale Standard Deviation 12.4571	-21.280 score on a scale Standard Deviation 12.9457
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 76	—	—	—	—	-14.621 score on a scale Standard Deviation 14.7575	-14.977 score on a scale Standard Deviation 11.4630	-17.514 score on a scale Standard Deviation 12.1319	-20.696 score on a scale Standard Deviation 12.4896
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 80	—	—	—	—	-14.289 score on a scale Standard Deviation 15.0957	-15.888 score on a scale Standard Deviation 11.9316	-17.069 score on a scale Standard Deviation 11.6199	-20.822 score on a scale Standard Deviation 13.5723
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 84	—	—	—	—	-14.906 score on a scale Standard Deviation 15.1056	-15.419 score on a scale Standard Deviation 11.9932	-17.233 score on a scale Standard Deviation 11.9661	-20.485 score on a scale Standard Deviation 14.2038
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-15.079 score on a scale Standard Deviation 12.8557	-15.423 score on a scale Standard Deviation 12.0649	-15.476 score on a scale Standard Deviation 13.3711	-18.833 score on a scale Standard Deviation 14.4014
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-14.017 score on a scale Standard Deviation 13.8170	-14.150 score on a scale Standard Deviation 11.6401	-17.282 score on a scale Standard Deviation 11.4617	-20.687 score on a scale Standard Deviation 14.6462
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-14.391 score on a scale Standard Deviation 14.1550	-14.612 score on a scale Standard Deviation 11.3920	-17.076 score on a scale Standard Deviation 9.4960	-19.520 score on a scale Standard Deviation 14.2756
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-13.538 score on a scale Standard Deviation 13.2755	-14.404 score on a scale Standard Deviation 11.6971	-16.800 score on a scale Standard Deviation 10.1413	-20.109 score on a scale Standard Deviation 15.3423
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-13.832 score on a scale Standard Deviation 14.8785	-14.912 score on a scale Standard Deviation 12.1638	-16.926 score on a scale Standard Deviation 11.5097	-19.939 score on a scale Standard Deviation 14.1463
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-13.251 score on a scale Standard Deviation 14.2737	-14.265 score on a scale Standard Deviation 11.9806	-16.856 score on a scale Standard Deviation 9.6991	-19.215 score on a scale Standard Deviation 13.0405
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-14.113 score on a scale Standard Deviation 13.7397	-14.904 score on a scale Standard Deviation 11.8237	-16.258 score on a scale Standard Deviation 11.2435	-20.439 score on a scale Standard Deviation 13.0531
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-14.732 score on a scale Standard Deviation 14.5591	-15.492 score on a scale Standard Deviation 11.6393	-15.386 score on a scale Standard Deviation 12.5672	-20.611 score on a scale Standard Deviation 12.3814
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-14.706 score on a scale Standard Deviation 14.9924	-14.619 score on a scale Standard Deviation 12.0768	-16.788 score on a scale Standard Deviation 11.9283	-20.348 score on a scale Standard Deviation 12.9401
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Baseline	30.694 score on a scale Standard Deviation 10.7598	30.546 score on a scale Standard Deviation 12.5152	31.646 score on a scale Standard Deviation 9.3821	34.413 score on a scale Standard Deviation 12.6292	30.317 score on a scale Standard Deviation 10.5425	30.604 score on a scale Standard Deviation 12.9983	30.962 score on a scale Standard Deviation 8.2366	33.915 score on a scale Standard Deviation 11.9378
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 2	-5.093 score on a scale Standard Deviation 8.0941	-5.618 score on a scale Standard Deviation 6.0585	-6.704 score on a scale Standard Deviation 6.9970	-6.352 score on a scale Standard Deviation 9.5528	-5.800 score on a scale Standard Deviation 6.9371	-5.458 score on a scale Standard Deviation 6.1238	-6.434 score on a scale Standard Deviation 6.8409	-6.539 score on a scale Standard Deviation 9.9950
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 4	-5.722 score on a scale Standard Deviation 8.8627	-4.889 score on a scale Standard Deviation 7.3568	-7.948 score on a scale Standard Deviation 7.1614	-9.819 score on a scale Standard Deviation 11.2688	-6.560 score on a scale Standard Deviation 8.0631	-4.754 score on a scale Standard Deviation 7.0439	-8.050 score on a scale Standard Deviation 6.9054	-10.433 score on a scale Standard Deviation 11.8548
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 12	-7.546 score on a scale Standard Deviation 13.0215	-10.132 score on a scale Standard Deviation 10.8337	-12.089 score on a scale Standard Deviation 10.0806	-13.383 score on a scale Standard Deviation 14.5075	-9.660 score on a scale Standard Deviation 9.8693	-10.438 score on a scale Standard Deviation 10.8236	-12.688 score on a scale Standard Deviation 9.5421	-14.861 score on a scale Standard Deviation 15.0025
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 16	-9.294 score on a scale Standard Deviation 13.2176	-12.043 score on a scale Standard Deviation 10.7104	-13.809 score on a scale Standard Deviation 9.8357	-14.152 score on a scale Standard Deviation 14.9552	-11.853 score on a scale Standard Deviation 9.8578	-12.565 score on a scale Standard Deviation 10.6334	-14.322 score on a scale Standard Deviation 9.4641	-16.617 score on a scale Standard Deviation 14.1166
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 20	-8.996 score on a scale Standard Deviation 14.7780	-12.446 score on a scale Standard Deviation 11.0107	-13.724 score on a scale Standard Deviation 11.8173	-15.011 score on a scale Standard Deviation 14.9433	-11.857 score on a scale Standard Deviation 11.8911	-13.112 score on a scale Standard Deviation 10.9374	-14.342 score on a scale Standard Deviation 11.5579	-17.626 score on a scale Standard Deviation 13.9147
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF Change at Week 24	-8.691 score on a scale Standard Deviation 14.3072	-12.671 score on a scale Standard Deviation 11.6001	-14.743 score on a scale Standard Deviation 11.6082	-14.883 score on a scale Standard Deviation 14.9074	-11.506 score on a scale Standard Deviation 11.2985	-13.354 score on a scale Standard Deviation 11.5619	-15.442 score on a scale Standard Deviation 11.2609	-17.698 score on a scale Standard Deviation 13.7260

SECONDARY outcome

Timeframe: Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.

The CDAI was calculated from tender joint counts of 28, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score, and CRP value. Total score ranged between 0-76. CDAI score of 22 or above = high disease activity, a value between 10 and 22 = moderate disease activity and value less than or equal to <=10 = low disease activity, value <=2.8 = disease remission. Higher scores indicated higher disease activity. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Baseline	29.198 score on a scale Standard Deviation 10.1188	29.104 score on a scale Standard Deviation 11.3057	30.563 score on a scale Standard Deviation 9.3260	33.169 score on a scale Standard Deviation 12.0220	28.900 score on a scale Standard Deviation 9.9333	29.196 score on a scale Standard Deviation 11.7439	29.918 score on a scale Standard Deviation 8.2741	32.848 score on a scale Standard Deviation 11.4735
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 2	-5.007 score on a scale Standard Deviation 7.9447	-5.336 score on a scale Standard Deviation 6.0158	-6.785 score on a scale Standard Deviation 6.8641	-6.424 score on a scale Standard Deviation 9.5389	-5.640 score on a scale Standard Deviation 6.8069	-5.142 score on a scale Standard Deviation 6.0961	-6.518 score on a scale Standard Deviation 6.7345	-6.663 score on a scale Standard Deviation 9.9570
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 4	-5.787 score on a scale Standard Deviation 8.3763	-5.093 score on a scale Standard Deviation 6.9306	-7.983 score on a scale Standard Deviation 7.0449	-10.152 score on a scale Standard Deviation 10.7576	-6.421 score on a scale Standard Deviation 7.7106	-4.904 score on a scale Standard Deviation 6.6827	-8.080 score on a scale Standard Deviation 6.8543	-10.713 score on a scale Standard Deviation 11.3327
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 8	-7.456 score on a scale Standard Deviation 11.9815	-7.754 score on a scale Standard Deviation 8.3585	-9.824 score on a scale Standard Deviation 9.4091	-12.809 score on a scale Standard Deviation 12.4854	-9.364 score on a scale Standard Deviation 9.0361	-7.704 score on a scale Standard Deviation 8.2942	-9.946 score on a scale Standard Deviation 9.3095	-13.778 score on a scale Standard Deviation 13.1305
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 12	-7.700 score on a scale Standard Deviation 12.4359	-9.900 score on a scale Standard Deviation 10.7410	-12.391 score on a scale Standard Deviation 9.5546	-13.335 score on a scale Standard Deviation 13.7520	-9.666 score on a scale Standard Deviation 9.4769	-10.177 score on a scale Standard Deviation 10.7463	-13.012 score on a scale Standard Deviation 8.9533	-14.617 score on a scale Standard Deviation 14.3068
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 16	-9.469 score on a scale Standard Deviation 12.5253	-11.786 score on a scale Standard Deviation 10.2476	-13.698 score on a scale Standard Deviation 9.5039	-14.243 score on a scale Standard Deviation 14.0490	-11.853 score on a scale Standard Deviation 9.2509	-12.273 score on a scale Standard Deviation 10.1616	-14.220 score on a scale Standard Deviation 9.1180	-16.541 score on a scale Standard Deviation 13.2391
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 20	-9.231 score on a scale Standard Deviation 14.0979	-12.279 score on a scale Standard Deviation 10.3590	-13.548 score on a scale Standard Deviation 11.4067	-15.113 score on a scale Standard Deviation 14.3180	-11.857 score on a scale Standard Deviation 11.3698	-12.862 score on a scale Standard Deviation 10.2616	-14.108 score on a scale Standard Deviation 11.1938	-17.487 score on a scale Standard Deviation 13.3908
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 24	-9.080 score on a scale Standard Deviation 13.2957	-12.411 score on a scale Standard Deviation 10.6684	-14.815 score on a scale Standard Deviation 11.3164	-15.361 score on a scale Standard Deviation 14.0888	-11.683 score on a scale Standard Deviation 10.2413	-13.004 score on a scale Standard Deviation 10.5902	-15.476 score on a scale Standard Deviation 11.0172	-18.000 score on a scale Standard Deviation 12.8580
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 28	—	—	—	—	-13.753 score on a scale Standard Deviation 11.1661	-14.519 score on a scale Standard Deviation 11.5712	-16.604 score on a scale Standard Deviation 11.5179	-18.700 score on a scale Standard Deviation 13.2130
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 32	—	—	—	—	-14.981 score on a scale Standard Deviation 11.8964	-15.108 score on a scale Standard Deviation 11.2046	-15.606 score on a scale Standard Deviation 12.5181	-18.478 score on a scale Standard Deviation 13.6585
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 36	—	—	—	—	-13.917 score on a scale Standard Deviation 13.0248	-14.015 score on a scale Standard Deviation 10.4490	-17.134 score on a scale Standard Deviation 10.9034	-20.450 score on a scale Standard Deviation 13.8226
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 40	—	—	—	—	-14.226 score on a scale Standard Deviation 13.3556	-14.315 score on a scale Standard Deviation 10.3937	-16.980 score on a scale Standard Deviation 9.3329	-19.274 score on a scale Standard Deviation 13.4909
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 44	—	—	—	—	-13.440 score on a scale Standard Deviation 12.6798	-14.058 score on a scale Standard Deviation 10.6267	-17.060 score on a scale Standard Deviation 9.8900	-19.941 score on a scale Standard Deviation 14.6274
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 48	—	—	—	—	-13.977 score on a scale Standard Deviation 14.2191	-14.658 score on a scale Standard Deviation 11.0874	-16.884 score on a scale Standard Deviation 11.0023	-19.624 score on a scale Standard Deviation 13.4005
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 56	—	—	—	—	-14.019 score on a scale Standard Deviation 12.9269	-14.462 score on a scale Standard Deviation 10.8608	-16.228 score on a scale Standard Deviation 10.8175	-20.167 score on a scale Standard Deviation 12.7089
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 60	—	—	—	—	-14.032 score on a scale Standard Deviation 12.9707	-15.400 score on a scale Standard Deviation 10.4881	-16.592 score on a scale Standard Deviation 11.8366	-20.354 score on a scale Standard Deviation 12.8739
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 64	—	—	—	—	-14.687 score on a scale Standard Deviation 13.6997	-15.150 score on a scale Standard Deviation 10.5316	-15.924 score on a scale Standard Deviation 11.5956	-20.215 score on a scale Standard Deviation 12.0216
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 68	—	—	—	—	-15.291 score on a scale Standard Deviation 13.2786	-13.958 score on a scale Standard Deviation 12.0080	-16.422 score on a scale Standard Deviation 11.7994	-20.917 score on a scale Standard Deviation 12.3462
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 72	—	—	—	—	-14.536 score on a scale Standard Deviation 13.7461	-14.346 score on a scale Standard Deviation 10.9159	-16.828 score on a scale Standard Deviation 11.2797	-20.063 score on a scale Standard Deviation 12.2151
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 80	—	—	—	—	-14.091 score on a scale Standard Deviation 14.0501	-15.565 score on a scale Standard Deviation 10.7890	-17.090 score on a scale Standard Deviation 11.0248	-20.420 score on a scale Standard Deviation 12.9597
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 52	—	—	—	—	-13.577 score on a scale Standard Deviation 13.4474	-14.031 score on a scale Standard Deviation 10.7633	-16.764 score on a scale Standard Deviation 9.4282	-19.076 score on a scale Standard Deviation 12.7465
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 76	—	—	—	—	-14.536 score on a scale Standard Deviation 13.4853	-14.600 score on a scale Standard Deviation 10.4240	-17.556 score on a scale Standard Deviation 11.5861	-20.289 score on a scale Standard Deviation 11.8557
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF Change at Week 84	—	—	—	—	-14.679 score on a scale Standard Deviation 13.9556	-15.031 score on a scale Standard Deviation 10.8769	-17.344 score on a scale Standard Deviation 11.2309	-20.139 score on a scale Standard Deviation 13.4967

SECONDARY outcome

Timeframe: Treatment Phase: Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using NRI imputation.

The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to <=5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 2 · Good response	3 Participants	1 Participants	2 Participants	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 2 · Moderate response	12 Participants	6 Participants	13 Participants	11 Participants	11 Participants	9 Participants	14 Participants	10 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 2 · No response	38 Participants	21 Participants	39 Participants	42 Participants	32 Participants	17 Participants	35 Participants	35 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 4 · Moderate response	15 Participants	9 Participants	22 Participants	20 Participants	14 Participants	8 Participants	21 Participants	18 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 4 · No response	37 Participants	19 Participants	31 Participants	32 Participants	31 Participants	18 Participants	28 Participants	26 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 8 · Good response	5 Participants	1 Participants	4 Participants	7 Participants	5 Participants	1 Participants	3 Participants	7 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 8 · Moderate response	19 Participants	13 Participants	26 Participants	28 Participants	17 Participants	12 Participants	26 Participants	24 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 8 · No response	30 Participants	14 Participants	24 Participants	19 Participants	25 Participants	13 Participants	21 Participants	15 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 12 · Good response	7 Participants	3 Participants	10 Participants	11 Participants	7 Participants	3 Participants	9 Participants	11 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 12 · No response	29 Participants	14 Participants	18 Participants	24 Participants	24 Participants	13 Participants	15 Participants	16 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 16 · Good response	10 Participants	5 Participants	10 Participants	9 Participants	10 Participants	5 Participants	10 Participants	9 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 16 · No response	22 Participants	12 Participants	15 Participants	21 Participants	16 Participants	11 Participants	11 Participants	14 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 20 · Good response	6 Participants	4 Participants	13 Participants	13 Participants	6 Participants	4 Participants	13 Participants	13 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 20 · Moderate response	20 Participants	15 Participants	23 Participants	23 Participants	20 Participants	14 Participants	23 Participants	23 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 20 · No response	28 Participants	9 Participants	18 Participants	18 Participants	21 Participants	8 Participants	14 Participants	10 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 24 · Moderate response	19 Participants	11 Participants	27 Participants	21 Participants	19 Participants	11 Participants	27 Participants	21 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 24 · No response	28 Participants	13 Participants	17 Participants	20 Participants	21 Participants	11 Participants	13 Participants	12 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 28 · Good response	—	—	—	—	11 Participants	6 Participants	12 Participants	13 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 32 · Good response	—	—	—	—	12 Participants	5 Participants	13 Participants	12 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 36 · Moderate response	—	—	—	—	25 Participants	11 Participants	29 Participants	22 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 36 · No response	—	—	—	—	11 Participants	11 Participants	9 Participants	10 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 44 · Good response	—	—	—	—	12 Participants	5 Participants	15 Participants	13 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 44 · Moderate response	—	—	—	—	19 Participants	9 Participants	24 Participants	22 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 48 · Good response	—	—	—	—	11 Participants	7 Participants	14 Participants	14 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 48 · Moderate response	—	—	—	—	23 Participants	7 Participants	23 Participants	20 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 52 · Good response	—	—	—	—	14 Participants	6 Participants	12 Participants	16 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 52 · Moderate response	—	—	—	—	15 Participants	8 Participants	22 Participants	18 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 52 · No response	—	—	—	—	18 Participants	12 Participants	16 Participants	12 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 56 · Good response	—	—	—	—	15 Participants	6 Participants	9 Participants	14 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 56 · Moderate response	—	—	—	—	16 Participants	10 Participants	27 Participants	23 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 56 · No response	—	—	—	—	16 Participants	10 Participants	14 Participants	9 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 60 · Good response	—	—	—	—	14 Participants	7 Participants	17 Participants	15 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 64 · Good response	—	—	—	—	14 Participants	8 Participants	13 Participants	15 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 64 · Moderate response	—	—	—	—	18 Participants	7 Participants	21 Participants	23 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 64 · No response	—	—	—	—	15 Participants	11 Participants	16 Participants	8 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 68 · Moderate response	—	—	—	—	17 Participants	8 Participants	19 Participants	20 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 68 · No response	—	—	—	—	15 Participants	12 Participants	16 Participants	9 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 72 · No response	—	—	—	—	18 Participants	11 Participants	18 Participants	12 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 76 · Good response	—	—	—	—	11 Participants	6 Participants	16 Participants	18 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 76 · Moderate response	—	—	—	—	19 Participants	9 Participants	16 Participants	19 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 76 · No response	—	—	—	—	17 Participants	11 Participants	18 Participants	9 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 80 · Good response	—	—	—	—	13 Participants	5 Participants	12 Participants	19 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 80 · Moderate response	—	—	—	—	16 Participants	11 Participants	21 Participants	16 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 84 · Good response	—	—	—	—	12 Participants	8 Participants	13 Participants	17 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 84 · Moderate response	—	—	—	—	21 Participants	7 Participants	21 Participants	17 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 84 · No response	—	—	—	—	14 Participants	11 Participants	16 Participants	12 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 4 · Good response	2 Participants	0 Participants	1 Participants	2 Participants	2 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 12 · Moderate response	18 Participants	11 Participants	26 Participants	19 Participants	16 Participants	10 Participants	26 Participants	19 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 16 · Moderate response	22 Participants	11 Participants	29 Participants	24 Participants	21 Participants	10 Participants	29 Participants	23 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 24 · Good response	7 Participants	4 Participants	10 Participants	13 Participants	7 Participants	4 Participants	10 Participants	13 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 28 · Moderate response	—	—	—	—	22 Participants	10 Participants	29 Participants	23 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 28 · No response	—	—	—	—	14 Participants	10 Participants	9 Participants	10 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 32 · Moderate response	—	—	—	—	19 Participants	13 Participants	26 Participants	22 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 32 · No response	—	—	—	—	16 Participants	8 Participants	11 Participants	12 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 36 · Good response	—	—	—	—	11 Participants	4 Participants	12 Participants	14 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 40 · Good response	—	—	—	—	12 Participants	5 Participants	15 Participants	13 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 40 · Moderate response	—	—	—	—	19 Participants	9 Participants	24 Participants	21 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 72 · Good response	—	—	—	—	11 Participants	4 Participants	13 Participants	18 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 40 · No response	—	—	—	—	16 Participants	12 Participants	11 Participants	12 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 44 · No response	—	—	—	—	16 Participants	12 Participants	11 Participants	11 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 48 · No response	—	—	—	—	13 Participants	12 Participants	13 Participants	12 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 60 · Moderate response	—	—	—	—	17 Participants	9 Participants	17 Participants	19 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 60 · No response	—	—	—	—	16 Participants	10 Participants	16 Participants	12 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 68 · Good response	—	—	—	—	15 Participants	6 Participants	15 Participants	17 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 72 · Moderate response	—	—	—	—	18 Participants	11 Participants	19 Participants	16 Participants
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI EULAR response at Week 80 · No response	—	—	—	—	18 Participants	10 Participants	17 Participants	11 Participants

SECONDARY outcome

Timeframe: Treatment Phase: Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using NRI.

The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 <=3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to <=5.1 or change from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: change from baseline <=0.6 or change from baseline >0.6 and <=1.2 with DAS28 >5.1. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 2 · Good response	3 Participants	1 Participants	2 Participants	0 Participants	3 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 2 · Moderate response	11 Participants	6 Participants	13 Participants	12 Participants	10 Participants	5 Participants	10 Participants	11 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 2 · No response	40 Participants	21 Participants	39 Participants	42 Participants	34 Participants	20 Participants	38 Participants	35 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 4 · Good response	2 Participants	0 Participants	3 Participants	3 Participants	2 Participants	0 Participants	3 Participants	3 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 4 · Moderate response	13 Participants	8 Participants	17 Participants	18 Participants	12 Participants	7 Participants	16 Participants	17 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 4 · No response	39 Participants	20 Participants	34 Participants	33 Participants	33 Participants	19 Participants	31 Participants	26 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 8 · Good response	5 Participants	1 Participants	8 Participants	6 Participants	5 Participants	1 Participants	7 Participants	6 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 8 · No response	35 Participants	15 Participants	27 Participants	25 Participants	29 Participants	14 Participants	24 Participants	19 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 12 · Good response	7 Participants	6 Participants	14 Participants	8 Participants	7 Participants	6 Participants	13 Participants	8 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 12 · Moderate response	16 Participants	8 Participants	17 Participants	21 Participants	15 Participants	7 Participants	17 Participants	21 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 12 · No response	31 Participants	14 Participants	23 Participants	25 Participants	25 Participants	13 Participants	20 Participants	17 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 16 · Good response	9 Participants	5 Participants	12 Participants	12 Participants	9 Participants	5 Participants	12 Participants	12 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 16 · Moderate response	20 Participants	10 Participants	23 Participants	18 Participants	19 Participants	9 Participants	23 Participants	16 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 16 · No response	25 Participants	13 Participants	19 Participants	24 Participants	19 Participants	12 Participants	15 Participants	18 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 20 · Good response	8 Participants	5 Participants	15 Participants	15 Participants	8 Participants	5 Participants	15 Participants	15 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 20 · Moderate response	17 Participants	12 Participants	21 Participants	17 Participants	17 Participants	12 Participants	21 Participants	17 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 20 · No response	29 Participants	11 Participants	18 Participants	22 Participants	22 Participants	9 Participants	14 Participants	14 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 24 · Good response	8 Participants	7 Participants	14 Participants	14 Participants	8 Participants	7 Participants	14 Participants	14 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 24 · Moderate response	17 Participants	6 Participants	18 Participants	17 Participants	17 Participants	6 Participants	18 Participants	17 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 24 · No response	29 Participants	15 Participants	22 Participants	23 Participants	22 Participants	13 Participants	18 Participants	15 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 28 · Good response	—	—	—	—	9 Participants	5 Participants	16 Participants	15 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 28 · Moderate response	—	—	—	—	23 Participants	12 Participants	21 Participants	17 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 28 · No response	—	—	—	—	15 Participants	9 Participants	13 Participants	14 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 32 · Good response	—	—	—	—	13 Participants	5 Participants	17 Participants	16 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 32 · No response	—	—	—	—	18 Participants	7 Participants	14 Participants	15 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 36 · Good response	—	—	—	—	12 Participants	5 Participants	16 Participants	17 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 36 · No response	—	—	—	—	12 Participants	10 Participants	12 Participants	9 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 40 · Moderate response	—	—	—	—	16 Participants	10 Participants	22 Participants	21 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 40 · No response	—	—	—	—	20 Participants	11 Participants	13 Participants	11 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 44 · Good response	—	—	—	—	11 Participants	5 Participants	16 Participants	16 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 44 · Moderate response	—	—	—	—	19 Participants	9 Participants	20 Participants	16 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 48 · Good response	—	—	—	—	11 Participants	7 Participants	17 Participants	17 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 48 · Moderate response	—	—	—	—	21 Participants	8 Participants	18 Participants	14 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 48 · No response	—	—	—	—	15 Participants	11 Participants	15 Participants	15 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 52 · Good response	—	—	—	—	16 Participants	7 Participants	12 Participants	18 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 52 · Moderate response	—	—	—	—	11 Participants	6 Participants	21 Participants	14 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 56 · Good response	—	—	—	—	16 Participants	6 Participants	15 Participants	21 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 56 · Moderate response	—	—	—	—	13 Participants	11 Participants	19 Participants	14 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 56 · No response	—	—	—	—	18 Participants	9 Participants	16 Participants	11 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 60 · Good response	—	—	—	—	15 Participants	8 Participants	16 Participants	18 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 60 · Moderate response	—	—	—	—	15 Participants	9 Participants	18 Participants	16 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 60 · No response	—	—	—	—	17 Participants	9 Participants	16 Participants	12 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 64 · Good response	—	—	—	—	12 Participants	7 Participants	15 Participants	19 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 64 · Moderate response	—	—	—	—	18 Participants	9 Participants	18 Participants	17 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 64 · No response	—	—	—	—	17 Participants	10 Participants	17 Participants	10 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 68 · Good response	—	—	—	—	16 Participants	7 Participants	17 Participants	18 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 68 · Moderate response	—	—	—	—	17 Participants	7 Participants	17 Participants	19 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 68 · No response	—	—	—	—	14 Participants	12 Participants	16 Participants	9 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 72 · Good response	—	—	—	—	12 Participants	7 Participants	19 Participants	18 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 72 · Moderate response	—	—	—	—	16 Participants	8 Participants	12 Participants	15 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 72 · No response	—	—	—	—	19 Participants	11 Participants	19 Participants	13 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 76 · Good response	—	—	—	—	15 Participants	7 Participants	18 Participants	20 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 76 · Moderate response	—	—	—	—	15 Participants	9 Participants	15 Participants	15 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 76 · No response	—	—	—	—	17 Participants	10 Participants	17 Participants	11 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 80 · Good response	—	—	—	—	15 Participants	8 Participants	14 Participants	22 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 80 · Moderate response	—	—	—	—	14 Participants	7 Participants	19 Participants	12 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 84 · No response	—	—	—	—	16 Participants	11 Participants	16 Participants	12 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 8 · Moderate response	14 Participants	12 Participants	19 Participants	23 Participants	13 Participants	11 Participants	19 Participants	21 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 32 · Moderate response	—	—	—	—	16 Participants	14 Participants	19 Participants	15 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 36 · Moderate response	—	—	—	—	23 Participants	11 Participants	22 Participants	20 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 40 · Good response	—	—	—	—	11 Participants	5 Participants	15 Participants	14 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 44 · No response	—	—	—	—	17 Participants	12 Participants	14 Participants	14 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 52 · No response	—	—	—	—	20 Participants	13 Participants	17 Participants	14 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 80 · No response	—	—	—	—	18 Participants	11 Participants	17 Participants	12 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 84 · Good response	—	—	—	—	15 Participants	8 Participants	19 Participants	22 Participants
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI EULAR response at Week 84 · Moderate response	—	—	—	—	16 Participants	7 Participants	15 Participants	12 Participants

SECONDARY outcome

Timeframe: Treatment Phase: Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, and 104

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using NRI.

The SDAI was calculated from tender joint counts of 28, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score, and CRP value. Total score ranged between 0-86. SDAI score of 26 or above = high disease activity, a value between 11 and 26 = moderate disease activity and value <=11 = low disease activity. Higher scores indicated higher disease activity. SDAI Remission was defined as SDAI score <=3.3. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 2	1.9 percentage of participants Interval 0.0 to 5.45	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	2.1 percentage of participants Interval 0.0 to 6.25	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 4	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	1.9 percentage of participants Interval 0.0 to 5.45	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	2.0 percentage of participants Interval 0.0 to 5.88	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 8	0.0 percentage of participants Interval 0.0 to 0.0	3.6 percentage of participants Interval 0.0 to 10.45	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	3.8 percentage of participants Interval 0.0 to 11.24	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 12	1.9 percentage of participants Interval 0.0 to 5.45	10.7 percentage of participants Interval 0.0 to 22.17	3.7 percentage of participants Interval 0.0 to 8.74	1.9 percentage of participants Interval 0.0 to 5.45	2.1 percentage of participants Interval 0.0 to 6.25	11.5 percentage of participants Interval 0.0 to 23.82	4.0 percentage of participants Interval 0.0 to 9.43	2.2 percentage of participants Interval 0.0 to 6.39
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 16	3.7 percentage of participants Interval 0.0 to 8.74	10.7 percentage of participants Interval 0.0 to 22.17	5.6 percentage of participants Interval 0.0 to 11.67	3.7 percentage of participants Interval 0.0 to 8.74	4.3 percentage of participants Interval 0.0 to 10.03	11.5 percentage of participants Interval 0.0 to 23.82	6.0 percentage of participants Interval 0.0 to 12.58	4.3 percentage of participants Interval 0.0 to 10.24
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 20	7.4 percentage of participants Interval 0.42 to 14.39	14.3 percentage of participants Interval 1.32 to 27.25	7.4 percentage of participants Interval 0.42 to 14.39	9.3 percentage of participants Interval 1.53 to 16.99	8.5 percentage of participants Interval 0.53 to 16.49	15.4 percentage of participants Interval 1.52 to 29.25	8.0 percentage of participants Interval 0.48 to 15.52	10.9 percentage of participants Interval 1.87 to 19.86
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 24	5.6 percentage of participants Interval 0.0 to 11.67	7.1 percentage of participants Interval 0.0 to 16.68	7.4 percentage of participants Interval 0.42 to 14.39	11.1 percentage of participants Interval 2.73 to 19.49	6.4 percentage of participants Interval 0.0 to 13.37	7.7 percentage of participants Interval 0.0 to 17.93	8.0 percentage of participants Interval 0.48 to 15.52	13.0 percentage of participants Interval 3.31 to 22.78
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 28	—	—	—	—	6.4 percentage of participants Interval 0.0 to 13.37	11.5 percentage of participants Interval 0.0 to 23.82	10.0 percentage of participants Interval 1.68 to 18.32	10.9 percentage of participants Interval 1.87 to 19.86
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 32	—	—	—	—	8.5 percentage of participants Interval 0.53 to 16.49	11.5 percentage of participants Interval 0.0 to 23.82	10.0 percentage of participants Interval 1.68 to 18.32	13.0 percentage of participants Interval 3.31 to 22.78
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 36	—	—	—	—	8.5 percentage of participants Interval 0.53 to 16.49	7.7 percentage of participants Interval 0.0 to 17.93	14.0 percentage of participants Interval 4.38 to 23.62	13.0 percentage of participants Interval 3.31 to 22.78
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 40	—	—	—	—	12.8 percentage of participants Interval 3.23 to 22.31	7.7 percentage of participants Interval 0.0 to 17.93	12.0 percentage of participants Interval 2.99 to 21.01	15.2 percentage of participants Interval 4.84 to 25.6
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 44	—	—	—	—	10.6 percentage of participants Interval 1.82 to 19.45	11.5 percentage of participants Interval 0.0 to 23.82	16.0 percentage of participants Interval 5.84 to 26.16	15.2 percentage of participants Interval 4.84 to 25.6
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 48	—	—	—	—	17.0 percentage of participants Interval 6.28 to 27.77	19.2 percentage of participants Interval 4.08 to 34.38	12.0 percentage of participants Interval 2.99 to 21.01	21.7 percentage of participants Interval 9.82 to 33.66
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 52	—	—	—	—	17.0 percentage of participants Interval 6.28 to 27.77	15.4 percentage of participants Interval 1.52 to 29.25	10.0 percentage of participants Interval 1.68 to 18.32	13.0 percentage of participants Interval 3.31 to 22.78
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 56	—	—	—	—	14.9 percentage of participants Interval 4.72 to 25.07	15.4 percentage of participants Interval 1.52 to 29.25	6.0 percentage of participants Interval 0.0 to 12.58	17.4 percentage of participants Interval 6.44 to 28.34
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 60	—	—	—	—	12.8 percentage of participants Interval 3.23 to 22.31	19.2 percentage of participants Interval 4.08 to 34.38	16.0 percentage of participants Interval 5.84 to 26.16	13.0 percentage of participants Interval 3.31 to 22.78
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 64	—	—	—	—	10.6 percentage of participants Interval 1.82 to 19.45	19.2 percentage of participants Interval 4.08 to 34.38	12.0 percentage of participants Interval 2.99 to 21.01	10.9 percentage of participants Interval 1.87 to 19.86
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 68	—	—	—	—	19.1 percentage of participants Interval 7.9 to 30.4	23.1 percentage of participants Interval 6.88 to 39.27	8.0 percentage of participants Interval 0.48 to 15.52	17.4 percentage of participants Interval 6.44 to 28.34
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 72	—	—	—	—	10.6 percentage of participants Interval 1.82 to 19.45	19.2 percentage of participants Interval 4.08 to 34.38	14.0 percentage of participants Interval 4.38 to 23.62	19.6 percentage of participants Interval 8.1 to 31.03
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 76	—	—	—	—	10.6 percentage of participants Interval 1.82 to 19.45	19.2 percentage of participants Interval 4.08 to 34.38	6.0 percentage of participants Interval 0.0 to 12.58	17.4 percentage of participants Interval 6.44 to 28.34
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 80	—	—	—	—	19.1 percentage of participants Interval 7.9 to 30.4	15.4 percentage of participants Interval 1.52 to 29.25	4.0 percentage of participants Interval 0.0 to 9.43	26.1 percentage of participants Interval 13.4 to 38.78
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI Remission at Week 84	—	—	—	—	17.0 percentage of participants Interval 6.28 to 27.77	23.1 percentage of participants Interval 6.88 to 39.27	12.0 percentage of participants Interval 2.99 to 21.01	23.9 percentage of participants Interval 11.59 to 36.24

SECONDARY outcome

Timeframe: Treatment Phase: Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using NRI.

The CDAI was calculated from tender joint counts of 28, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score, and CRP value. Total score ranged between 0-76. CDAI score of 22 or above = high disease activity, a value between 10 and 22 = moderate disease activity and value less than or equal to <=10 = low disease activity. Higher scores indicated higher disease activity. CDAI Remission was defined as CDAI score <=2.8. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 2	1.9 percentage of participants Interval 0.0 to 5.45	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	2.1 percentage of participants Interval 0.0 to 6.25	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 4	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 8	1.9 percentage of participants Interval 0.0 to 5.45	0.0 percentage of participants Interval 0.0 to 0.0	1.9 percentage of participants Interval 0.0 to 5.45	0.0 percentage of participants Interval 0.0 to 0.0	2.1 percentage of participants Interval 0.0 to 6.25	0.0 percentage of participants Interval 0.0 to 0.0	2.0 percentage of participants Interval 0.0 to 5.88	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 12	1.9 percentage of participants Interval 0.0 to 5.45	7.1 percentage of participants Interval 0.0 to 16.68	3.7 percentage of participants Interval 0.0 to 8.74	1.9 percentage of participants Interval 0.0 to 5.45	2.1 percentage of participants Interval 0.0 to 6.25	7.7 percentage of participants Interval 0.0 to 17.93	4.0 percentage of participants Interval 0.0 to 9.43	2.2 percentage of participants Interval 0.0 to 6.39
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 16	3.7 percentage of participants Interval 0.0 to 8.74	10.7 percentage of participants Interval 0.0 to 22.17	5.6 percentage of participants Interval 0.0 to 11.67	3.7 percentage of participants Interval 0.0 to 8.74	4.3 percentage of participants Interval 0.0 to 10.03	11.5 percentage of participants Interval 0.0 to 23.82	6.0 percentage of participants Interval 0.0 to 12.58	4.3 percentage of participants Interval 0.0 to 10.24
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 20	7.4 percentage of participants Interval 0.42 to 14.39	10.7 percentage of participants Interval 0.0 to 22.17	7.4 percentage of participants Interval 0.42 to 14.39	9.3 percentage of participants Interval 1.53 to 16.99	8.5 percentage of participants Interval 0.53 to 16.49	11.5 percentage of participants Interval 0.0 to 23.82	8.0 percentage of participants Interval 0.48 to 15.52	10.9 percentage of participants Interval 1.87 to 19.86
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 24	5.6 percentage of participants Interval 0.0 to 11.67	7.1 percentage of participants Interval 0.0 to 16.68	7.4 percentage of participants Interval 0.42 to 14.39	9.3 percentage of participants Interval 1.53 to 16.99	6.4 percentage of participants Interval 0.0 to 13.37	7.7 percentage of participants Interval 0.0 to 17.93	8.0 percentage of participants Interval 0.48 to 15.52	10.9 percentage of participants Interval 1.87 to 19.86
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 28	—	—	—	—	8.5 percentage of participants Interval 0.53 to 16.49	11.5 percentage of participants Interval 0.0 to 23.82	8.0 percentage of participants Interval 0.48 to 15.52	10.9 percentage of participants Interval 1.87 to 19.86
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 32	—	—	—	—	6.4 percentage of participants Interval 0.0 to 13.37	7.7 percentage of participants Interval 0.0 to 17.93	10.0 percentage of participants Interval 1.68 to 18.32	13.0 percentage of participants Interval 3.31 to 22.78
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 36	—	—	—	—	6.4 percentage of participants Interval 0.0 to 13.37	0.0 percentage of participants Interval 0.0 to 0.0	12.0 percentage of participants Interval 2.99 to 21.01	15.2 percentage of participants Interval 4.84 to 25.6
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 40	—	—	—	—	8.5 percentage of participants Interval 0.53 to 16.49	3.8 percentage of participants Interval 0.0 to 11.24	8.0 percentage of participants Interval 0.48 to 15.52	13.0 percentage of participants Interval 3.31 to 22.78
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 44	—	—	—	—	8.5 percentage of participants Interval 0.53 to 16.49	7.7 percentage of participants Interval 0.0 to 17.93	16.0 percentage of participants Interval 5.84 to 26.16	15.2 percentage of participants Interval 4.84 to 25.6
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 48	—	—	—	—	17.0 percentage of participants Interval 6.28 to 27.77	11.5 percentage of participants Interval 0.0 to 23.82	12.0 percentage of participants Interval 2.99 to 21.01	19.6 percentage of participants Interval 8.1 to 31.03
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 52	—	—	—	—	19.1 percentage of participants Interval 7.9 to 30.4	7.7 percentage of participants Interval 0.0 to 17.93	8.0 percentage of participants Interval 0.48 to 15.52	13.0 percentage of participants Interval 3.31 to 22.78
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 56	—	—	—	—	10.6 percentage of participants Interval 1.82 to 19.45	7.7 percentage of participants Interval 0.0 to 17.93	8.0 percentage of participants Interval 0.48 to 15.52	17.4 percentage of participants Interval 6.44 to 28.34
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 60	—	—	—	—	12.8 percentage of participants Interval 3.23 to 22.31	11.5 percentage of participants Interval 0.0 to 23.82	14.0 percentage of participants Interval 4.38 to 23.62	13.0 percentage of participants Interval 3.31 to 22.78
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 64	—	—	—	—	8.5 percentage of participants Interval 0.53 to 16.49	19.2 percentage of participants Interval 4.08 to 34.38	12.0 percentage of participants Interval 2.99 to 21.01	10.9 percentage of participants Interval 1.87 to 19.86
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 68	—	—	—	—	19.1 percentage of participants Interval 7.9 to 30.4	19.2 percentage of participants Interval 4.08 to 34.38	8.0 percentage of participants Interval 0.48 to 15.52	19.6 percentage of participants Interval 8.1 to 31.03
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 72	—	—	—	—	10.6 percentage of participants Interval 1.82 to 19.45	15.4 percentage of participants Interval 1.52 to 29.25	12.0 percentage of participants Interval 2.99 to 21.01	17.4 percentage of participants Interval 6.44 to 28.34
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 76	—	—	—	—	10.6 percentage of participants Interval 1.82 to 19.45	7.7 percentage of participants Interval 0.0 to 17.93	8.0 percentage of participants Interval 0.48 to 15.52	19.6 percentage of participants Interval 8.1 to 31.03
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 80	—	—	—	—	19.1 percentage of participants Interval 7.9 to 30.4	15.4 percentage of participants Interval 1.52 to 29.25	2.0 percentage of participants Interval 0.0 to 5.88	23.9 percentage of participants Interval 11.59 to 36.24
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI Remission at Week 84	—	—	—	—	14.9 percentage of participants Interval 4.72 to 25.07	23.1 percentage of participants Interval 6.88 to 39.27	10.0 percentage of participants Interval 1.68 to 18.32	23.9 percentage of participants Interval 11.59 to 36.24

SECONDARY outcome

Timeframe: Treatment Phase: Weeks 2, 4, 8, 12, 16, 20, and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, and 84

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using NRI.

Boolean remission criteria was defined as: tender joint count 68 <=1; swollen joint count 68 <=1; CRP <=1 mg/dL; and disease activity assessments VAS (mm) by participants <=1. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 80	—	—	—	—	8.5 percentage of participants Interval 0.53 to 16.49	11.5 percentage of participants Interval 0.0 to 23.82	6.0 percentage of participants Interval 0.0 to 12.58	19.6 percentage of participants Interval 8.1 to 31.03
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 2	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 4	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	1.9 percentage of participants Interval 0.0 to 5.45	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	2.0 percentage of participants Interval 0.0 to 5.88	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 8	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0	0.0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 12	1.9 percentage of participants Interval 0.0 to 5.45	3.6 percentage of participants Interval 0.0 to 10.45	3.7 percentage of participants Interval 0.0 to 8.74	3.7 percentage of participants Interval 0.0 to 8.74	2.1 percentage of participants Interval 0.0 to 6.25	3.8 percentage of participants Interval 0.0 to 11.24	4.0 percentage of participants Interval 0.0 to 9.43	4.3 percentage of participants Interval 0.0 to 10.24
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 16	1.9 percentage of participants Interval 0.0 to 5.45	7.1 percentage of participants Interval 0.0 to 16.68	3.7 percentage of participants Interval 0.0 to 8.74	3.7 percentage of participants Interval 0.0 to 8.74	2.1 percentage of participants Interval 0.0 to 6.25	7.7 percentage of participants Interval 0.0 to 17.93	4.0 percentage of participants Interval 0.0 to 9.43	4.3 percentage of participants Interval 0.0 to 10.24
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 20	0.0 percentage of participants Interval 0.0 to 0.0	3.6 percentage of participants Interval 0.0 to 10.45	3.7 percentage of participants Interval 0.0 to 8.74	9.3 percentage of participants Interval 1.53 to 16.99	0.0 percentage of participants Interval 0.0 to 0.0	3.8 percentage of participants Interval 0.0 to 11.24	4.0 percentage of participants Interval 0.0 to 9.43	10.9 percentage of participants Interval 1.87 to 19.86
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 24	1.9 percentage of participants Interval 0.0 to 5.45	3.6 percentage of participants Interval 0.0 to 10.45	5.6 percentage of participants Interval 0.0 to 11.67	5.6 percentage of participants Interval 0.0 to 11.67	2.1 percentage of participants Interval 0.0 to 6.25	3.8 percentage of participants Interval 0.0 to 11.24	6.0 percentage of participants Interval 0.0 to 12.58	6.5 percentage of participants Interval 0.0 to 13.66
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 28	—	—	—	—	4.3 percentage of participants Interval 0.0 to 10.03	7.7 percentage of participants Interval 0.0 to 17.93	8.0 percentage of participants Interval 0.48 to 15.52	6.5 percentage of participants Interval 0.0 to 13.66
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 32	—	—	—	—	0.0 percentage of participants Interval 0.0 to 0.0	7.7 percentage of participants Interval 0.0 to 17.93	6.0 percentage of participants Interval 0.0 to 12.58	8.7 percentage of participants Interval 0.55 to 16.84
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 36	—	—	—	—	2.1 percentage of participants Interval 0.0 to 6.25	7.7 percentage of participants Interval 0.0 to 17.93	10.0 percentage of participants Interval 1.68 to 18.32	8.7 percentage of participants Interval 0.55 to 16.84
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 40	—	—	—	—	4.3 percentage of participants Interval 0.0 to 10.03	11.5 percentage of participants Interval 0.0 to 23.82	4.0 percentage of participants Interval 0.0 to 9.43	8.7 percentage of participants Interval 0.55 to 16.84
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 44	—	—	—	—	2.1 percentage of participants Interval 0.0 to 6.25	7.7 percentage of participants Interval 0.0 to 17.93	14.0 percentage of participants Interval 4.38 to 23.62	8.7 percentage of participants Interval 0.55 to 16.84
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 48	—	—	—	—	4.3 percentage of participants Interval 0.0 to 10.03	7.7 percentage of participants Interval 0.0 to 17.93	10.0 percentage of participants Interval 1.68 to 18.32	15.2 percentage of participants Interval 4.84 to 25.6
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 52	—	—	—	—	6.4 percentage of participants Interval 0.0 to 13.37	3.8 percentage of participants Interval 0.0 to 11.24	6.0 percentage of participants Interval 0.0 to 12.58	8.7 percentage of participants Interval 0.55 to 16.84
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 56	—	—	—	—	4.3 percentage of participants Interval 0.0 to 10.03	7.7 percentage of participants Interval 0.0 to 17.93	6.0 percentage of participants Interval 0.0 to 12.58	10.9 percentage of participants Interval 1.87 to 19.86
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 60	—	—	—	—	6.4 percentage of participants Interval 0.0 to 13.37	7.7 percentage of participants Interval 0.0 to 17.93	10.0 percentage of participants Interval 1.68 to 18.32	6.5 percentage of participants Interval 0.0 to 13.66
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 64	—	—	—	—	10.6 percentage of participants Interval 1.82 to 19.45	7.7 percentage of participants Interval 0.0 to 17.93	6.0 percentage of participants Interval 0.0 to 12.58	8.7 percentage of participants Interval 0.55 to 16.84
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 68	—	—	—	—	10.6 percentage of participants Interval 1.82 to 19.45	11.5 percentage of participants Interval 0.0 to 23.82	6.0 percentage of participants Interval 0.0 to 12.58	8.7 percentage of participants Interval 0.55 to 16.84
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 72	—	—	—	—	6.4 percentage of participants Interval 0.0 to 13.37	7.7 percentage of participants Interval 0.0 to 17.93	8.0 percentage of participants Interval 0.48 to 15.52	15.2 percentage of participants Interval 4.84 to 25.6
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 76	—	—	—	—	2.1 percentage of participants Interval 0.0 to 6.25	11.5 percentage of participants Interval 0.0 to 23.82	4.0 percentage of participants Interval 0.0 to 9.43	15.2 percentage of participants Interval 4.84 to 25.6
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI Remission at Week 84	—	—	—	—	8.5 percentage of participants Interval 0.53 to 16.49	11.5 percentage of participants Interval 0.0 to 23.82	6.0 percentage of participants Interval 0.0 to 12.58	19.6 percentage of participants Interval 8.1 to 31.03

SECONDARY outcome

Timeframe: Treatment Phase: Baseline and Week 24; Extension Phase: Baseline, Weeks 24, 52, 76, and 104

Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed "n" are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using OC.

The mTSS was a measure of change in joint health. X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 [normal] to 528 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of <=0.5. Data reported for the Extension Phase from Baseline and Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.

Outcome measures

Measure	Treatment Phase: Placebo n=54 Participants During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 Participants During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 Participants During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 Participants During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 Participants Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 Participants Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 Participants Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 Participants Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) Baseline	27.20 units on a scale Standard Deviation 46.948	30.00 units on a scale Standard Deviation 36.582	37.55 units on a scale Standard Deviation 56.095	27.64 units on a scale Standard Deviation 40.621	17.08 units on a scale Standard Deviation 25.897	29.11 units on a scale Standard Deviation 34.551	31.61 units on a scale Standard Deviation 47.092	26.19 units on a scale Standard Deviation 35.524
Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) Change at Week 24	1.31 units on a scale Standard Deviation 2.639	2.54 units on a scale Standard Deviation 4.768	1.82 units on a scale Standard Deviation 4.075	1.34 units on a scale Standard Deviation 3.106	1.01 units on a scale Standard Deviation 1.929	1.20 units on a scale Standard Deviation 3.092	0.95 units on a scale Standard Deviation 3.392	0.49 units on a scale Standard Deviation 1.438
Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) Change at Week 52	—	—	—	—	2.37 units on a scale Standard Deviation 4.302	3.11 units on a scale Standard Deviation 4.711	3.35 units on a scale Standard Deviation 10.366	1.33 units on a scale Standard Deviation 3.559
Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) Change at Week 76	—	—	—	—	3.00 units on a scale Standard Deviation 5.931	3.61 units on a scale Standard Deviation 5.631	3.96 units on a scale Standard Deviation 14.378	1.63 units on a scale Standard Deviation 3.992
Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) Change at Week 104	—	—	—	—	3.49 units on a scale Standard Deviation 6.643	4.02 units on a scale Standard Deviation 5.598	4.70 units on a scale Standard Deviation 17.549	1.57 units on a scale Standard Deviation 3.885

Adverse Events

Treatment Phase: Placebo

Serious events: 2 serious events

Other events: 34 other events

Deaths: 0 deaths

Treatment Phase: E6011 100 mg

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Treatment Phase: E6011 200 mg

Serious events: 2 serious events

Other events: 38 other events

Deaths: 0 deaths

Treatment Phase: E6011 400/200 mg

Serious events: 3 serious events

Other events: 43 other events

Deaths: 0 deaths

Extension Phase: Placebo

Serious events: 4 serious events

Other events: 46 other events

Deaths: 0 deaths

Extension Phase: E6011 100 mg

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Extension Phase: E6011 200 mg

Serious events: 7 serious events

Other events: 50 other events

Deaths: 0 deaths

Extension Phase: E6011 400/200 mg

Serious events: 6 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Phase: Placebo n=54 participants at risk During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 participants at risk During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 participants at risk During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 participants at risk During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 participants at risk Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 participants at risk Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 participants at risk Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 participants at risk Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Blood and lymphatic system disorders Anaemia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Diverticulitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Pyelonephritis acute	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Sepsis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Radius fracture	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Ulna fracture	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Facial paralysis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Renal and urinary disorders Ureterolithiasis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Inguinal hernia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Vascular stent restenosis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Bronchitis bacterial	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Pneumonia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Pneumonia bacterial	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Pharyngitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Extremity contracture	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Cerebral infarction	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Presyncope	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Seizure	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Renal and urinary disorders Nephrolithiasis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])

Other adverse events

Measure	Treatment Phase: Placebo n=54 participants at risk During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 100 mg n=28 participants at risk During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 200 mg n=54 participants at risk During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Treatment Phase: E6011 400/200 mg n=54 participants at risk During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase.	Extension Phase: Placebo n=47 participants at risk Participants who received E6011-matched placebo and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 100 mg n=26 participants at risk Participants who received E6011 100 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 200 mg n=50 participants at risk Participants who received E6011 200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.	Extension Phase: E6011 400/200 mg n=46 participants at risk Participants who received E6011 400/200 mg and completed evaluations of the Treatment Phase at Week 24, entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Asteatosis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Rheumatoid nodule	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Osteoporosis	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Dizziness	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Dysgeusia	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Blood and lymphatic system disorders Anaemia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.4% 3/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	11.5% 3/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.7% 4/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Blood and lymphatic system disorders Lymphadenopathy	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Cardiac disorders Bradycardia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Cardiac disorders Cardiac failure	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Cardiac disorders Ventricular extrasystoles	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Ear and labyrinth disorders Vertigo	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.5% 3/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Ear and labyrinth disorders Vertigo positional	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Dry eye	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Corneal disorder	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Eye discharge	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Eyelid oedema	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Lacrimation increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Vitreous floaters	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Asthenopia	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Blepharitis	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Cataract	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Ocular hyperaemia	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Stomatitis	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	9.3% 5/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.4% 3/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.7% 2/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.0% 3/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	15.2% 7/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Dental caries	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	5.6% 3/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	10.9% 5/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Abdominal discomfort	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.0% 4/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Constipation	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.4% 3/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Diarrhoea	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	15.4% 4/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Abdominal pain upper	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Duodenal ulcer	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Gastrooesophageal reflux disease	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Nausea	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	11.5% 3/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.0% 3/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Tooth loss	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Hiatus hernia	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Mouth haemorrhage	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Injection site bruising	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Injection site erythema	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.0% 3/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.5% 3/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Injection site reaction	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.7% 2/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.0% 3/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Injection site pruritus	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Pyrexia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Chest discomfort	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Chills	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Injection site rash	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Injection site swelling	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Malaise	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Oedema peripheral	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Fatigue	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Injection site pain	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Hepatobiliary disorders Hepatic function abnormal	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	10.0% 5/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Immune system disorders Allergy to arthropod sting	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Nasopharyngitis	29.6% 16/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	25.0% 7/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	18.5% 10/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	33.3% 18/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	59.6% 28/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	57.7% 15/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	60.0% 30/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	60.9% 28/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Upper respiratory tract infection	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.1% 2/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.4% 4/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.5% 4/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	11.5% 3/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	14.0% 7/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.7% 4/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Bronchitis	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.1% 2/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	5.6% 3/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.5% 4/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	11.5% 3/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.0% 3/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	10.9% 5/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Pharyngitis	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	5.6% 3/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.5% 4/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.7% 2/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.0% 4/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.7% 4/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Folliculitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Laryngitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Oral herpes	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Paronychia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Pneumonia	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Tonsillitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Angular cheilitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.5% 3/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Conjunctivitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Enteritis infectious	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Gingivitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Herpes zoster	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.4% 3/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	15.4% 4/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Infected skin ulcer	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Influenza	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	12.8% 6/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.7% 2/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Otitis media	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Pneumonia pneumococcal	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Rhinitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.5% 3/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Sinusitis	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Urinary tract infection	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Acute sinusitis	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Gastroenteritis	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.5% 4/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.0% 3/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.5% 3/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Gingival abscess	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Lung infection	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Pyelonephritis	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Tinea pedis	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Contusion	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.7% 2/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	10.0% 5/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.7% 4/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Thermal burn	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.7% 2/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Chillblains	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Excoriation	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Ligament sprain	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Mouth injury	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Nasal injury	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Cell marker increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Lymphocyte count decreased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Blood alkaline phosphatase increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Blood uric acid increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations C-reactive protein increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations CD4 lymphocytes decreased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Fibrin D dimer increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Gamma-glutamyltransferase increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Liver function test increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Low density lipoprotein increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Procalcitonin increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Transaminases increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations White blood cell count decreased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations White blood cell count increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Metabolism and nutrition disorders Decreased appetite	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Metabolism and nutrition disorders Dehydration	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Back pain	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	5.6% 3/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.5% 4/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.7% 2/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.0% 3/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	13.0% 6/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.7% 2/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.0% 3/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Headache	5.6% 3/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	10.6% 5/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Hypoaesthesia	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Memory impairment	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Presyncope	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Sciatica	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Vagus nerve disorder	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Psychiatric disorders Insomnia	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.4% 3/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Psychiatric disorders Somatic symptom disorder	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Renal and urinary disorders Hypertonic bladder	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Renal and urinary disorders Renal impairment	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.0% 4/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	10.9% 5/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Respiratory, thoracic and mediastinal disorders Cough	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.4% 3/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.7% 2/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Rash	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.7% 2/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Dermatitis contact	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.0% 3/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Eczema	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.7% 2/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.0% 4/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Blister	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Eczema asteatotic	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Hyperkeratosis	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.7% 2/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.0% 4/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Dermal cyst	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Pruritus	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Vascular disorders Hypertension	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.6% 1/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.5% 4/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	11.5% 3/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Vascular disorders Lymphoedema	1.9% 1/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Cardiac disorders Myocardial ischaemia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Cardiac disorders Supraventricular extrasystoles	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Ear and labyrinth disorders Ear discomfort	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Ear and labyrinth disorders Meniere's disease	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Endocrine disorders Autoimmune thyroiditis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Cataract subcapsular	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Conjunctival haemorrhage	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Conjunctivitis allergic	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Eye pruritus	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Glaucoma	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Metamorphopsia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Retinal haemorrhage	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Visual impairment	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Eye disorders Dacryostenosis acquired	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Large intestine polyp	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.5% 3/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Abdominal distension	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Cheilitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Colitis ischaemic	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Enteritis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Enterocolitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Faeces soft	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Gastric ulcer	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Gastritis erosive	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Haematochezia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Leukoplakia oral	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Lip ulceration	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Periodontal disease	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Toothache	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Vomiting	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Gastritis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Gastrointestinal disorders Haemorrhoids	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Chest pain	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Pain	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
General disorders Peripheral swelling	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Hepatobiliary disorders Hepatic steatosis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Hepatobiliary disorders Cholelithiasis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Immune system disorders Seasonal allergy	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Cystitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Periodontitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Dermatophytosis of nail	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Otitis externa	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Bacterial vulvovaginitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Body tinea	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Helicobacter gastritis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Herpes simplex	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Hordeolum	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Pulpitis dental	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Skin infection	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Tracheobronchitis mycoplasmal	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Dacryocystitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Diverticulitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Eyelid folliculitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Gastroenteritis viral	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Bronchitis bacterial	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Onychomycosis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Infections and infestations Subcutaneous abscess	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.0% 3/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Fall	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Animal scratch	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Dislocation of vertebra	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Foot fracture	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Iliotibial band syndrome	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Laceration	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Injury, poisoning and procedural complications Lip injury	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Blood urine present	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Chest X-ray abnormal	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Hepatic enzyme increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Human chorionic gonadotropin increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Liver function test abnormal	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Mycobacterium tuberculosis complex test positive	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Weight increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Blood triglycerides increased	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Investigations Double stranded DNA antibody positive	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.0% 2/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	7.7% 2/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Nodal osteoarthritis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Atlantoaxial instability	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoproliferative disorder	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pyogenic granuloma	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Carpal tunnel syndrome	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	4.3% 2/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Cervicobrachial syndrome	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Dementia Alzheimer's type	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Dyslalia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Migraine	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Neuropathy peripheral	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Somnolence	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Tension headache	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Tremor	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Dizziness postural	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Essential tremor	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Intercostal neuralgia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Nervous system disorders Peroneal nerve palsy	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Psychiatric disorders Bulimia nervosa	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Renal and urinary disorders Diabetic nephropathy	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Renal and urinary disorders Haematuria	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Renal and urinary disorders Pelvi-ureteric obstruction	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Reproductive system and breast disorders Breast cyst	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Reproductive system and breast disorders Cystocele	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	3.8% 1/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.0% 3/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	8.7% 4/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.4% 3/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	6.4% 3/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Prurigo	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Skin and subcutaneous tissue disorders Solar lentigo	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.1% 1/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Vascular disorders Internal haemorrhage	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.2% 1/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])
Vascular disorders Hypotension	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/28 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/54 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/47 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/26 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	2.0% 1/50 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])	0.00% 0/46 • From the first dose of study drug up to 104 Weeks (Treatment Phase: From the first dose of study drug till Week 24; Extension Phase: Post Week 24 till Week 104])

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• Publication restrictions are in place