Trial Outcomes & Findings for Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain (NCT NCT03245008)

Last Updated: 2026-01-07

Results Overview

The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

626 participants

Primary outcome timeframe

Baseline to Week 16

Results posted on

2026-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Pooled Placebo This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	Pooled MT-5547 1 mg q4w This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment MT-5547 1 mg q8w This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 3 mg q4w This group was removed from this study dosing regimen after protocol amendment. Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 6 mg q8w This group was removed from this study dosing regimen after protocol amendment. Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.
Overall Study STARTED	204	203	162	28	29
Overall Study COMPLETED	164	159	132	0	0
Overall Study NOT COMPLETED	40	44	30	28	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Pooled Placebo This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	Pooled MT-5547 1 mg q4w This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment MT-5547 1 mg q8w This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 3 mg q4w This group was removed from this study dosing regimen after protocol amendment. Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 6 mg q8w This group was removed from this study dosing regimen after protocol amendment. Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.
Overall Study Lost to Follow-up	4	1	0	0	1
Overall Study Adverse Event	15	18	15	0	1
Overall Study Lack of Efficacy	0	1	0	0	0
Overall Study Physician Decision	1	3	4	0	0
Overall Study Protocol Violation	0	1	0	0	0
Overall Study Withdrawal by Subject	20	19	11	0	0
Overall Study Discontinuation of 3 mg q4w and 6 mg q8w doses	0	0	0	27	27
Overall Study Failure to meet randomization criteria	0	1	0	1	0

Baseline Characteristics

Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pooled Placebo n=204 Participants This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	Pooled MT-5547 1 mg q4w n=203 Participants This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment MT-5547 1 mg q8w n=162 Participants This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 3 mg q4w n=28 Participants This group was removed from this study dosing regimen after protocol amendment. Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 6 mg q8w n=29 Participants This group was removed from this study dosing regimen after protocol amendment. Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	Total n=626 Participants Total of all reporting groups
Age, Continuous	67.1 years STANDARD_DEVIATION 9.4 • n=37 Participants	66.1 years STANDARD_DEVIATION 9.7 • n=56 Participants	66.6 years STANDARD_DEVIATION 9.4 • n=95 Participants	68.6 years STANDARD_DEVIATION 7.6 • n=61 Participants	65.2 years STANDARD_DEVIATION 7.4 • n=5 Participants	66.6 years STANDARD_DEVIATION 9.3 • n=25 Participants
Sex: Female, Male Female	163 Participants n=37 Participants	160 Participants n=56 Participants	126 Participants n=95 Participants	20 Participants n=61 Participants	25 Participants n=5 Participants	494 Participants n=25 Participants
Sex: Female, Male Male	41 Participants n=37 Participants	43 Participants n=56 Participants	36 Participants n=95 Participants	8 Participants n=61 Participants	4 Participants n=5 Participants	132 Participants n=25 Participants
Race/Ethnicity, Customized Japanese	204 Participants n=37 Participants	203 Participants n=56 Participants	162 Participants n=95 Participants	28 Participants n=61 Participants	29 Participants n=5 Participants	626 Participants n=25 Participants
BMI	26.6 kg/㎡ STANDARD_DEVIATION 4.3 • n=37 Participants	27.0 kg/㎡ STANDARD_DEVIATION 4.4 • n=56 Participants	26.8 kg/㎡ STANDARD_DEVIATION 4.2 • n=95 Participants	24.8 kg/㎡ STANDARD_DEVIATION 3.4 • n=61 Participants	27.3 kg/㎡ STANDARD_DEVIATION 4.5 • n=5 Participants	26.8 kg/㎡ STANDARD_DEVIATION 4.3 • n=25 Participants
Index Joint Knee	189 Participants n=37 Participants	190 Participants n=56 Participants	150 Participants n=95 Participants	26 Participants n=61 Participants	26 Participants n=5 Participants	581 Participants n=25 Participants
Index Joint Hip	15 Participants n=37 Participants	13 Participants n=56 Participants	12 Participants n=95 Participants	2 Participants n=61 Participants	3 Participants n=5 Participants	45 Participants n=25 Participants
K-L Score 1	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants	0 Participants n=61 Participants	0 Participants n=5 Participants	0 Participants n=25 Participants
K-L Score 2	39 Participants n=37 Participants	36 Participants n=56 Participants	24 Participants n=95 Participants	2 Participants n=61 Participants	3 Participants n=5 Participants	104 Participants n=25 Participants
K-L Score 3	95 Participants n=37 Participants	97 Participants n=56 Participants	82 Participants n=95 Participants	15 Participants n=61 Participants	15 Participants n=5 Participants	304 Participants n=25 Participants
K-L Score 4	70 Participants n=37 Participants	70 Participants n=56 Participants	56 Participants n=95 Participants	11 Participants n=61 Participants	11 Participants n=5 Participants	218 Participants n=25 Participants
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score	5.93 units on a scale STANDARD_DEVIATION 1.33 • n=37 Participants	6.01 units on a scale STANDARD_DEVIATION 1.31 • n=56 Participants	6.02 units on a scale STANDARD_DEVIATION 1.39 • n=95 Participants	6.32 units on a scale STANDARD_DEVIATION 1.51 • n=61 Participants	6.34 units on a scale STANDARD_DEVIATION 1.29 • n=5 Participants	6.02 units on a scale STANDARD_DEVIATION 1.35 • n=25 Participants

PRIMARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week treatment period dataset, 24-week treatment period dataset, and 68-week treatment period dataset. The results in this section are presented in the 16-week treatment period dataset.

Outcome measures

Outcome measures
Measure	Pooled Placebo n=204 Participants This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	Pooled MT-5547 1 mg q4w n=203 Participants This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment Placebo n=165 Participants Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.	After the Amendment MT-5547 1 mg q8w n=162 Participants This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment MT-5547 1 mg q4w n=165 Participants Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48. These participants were included in the pooled MT-5547 1mg q4w group.
WOMAC Pain Score (Change From Baseline at Week 16)	-1.74 units on a scale Standard Error 0.17	-2.96 units on a scale Standard Error 0.17	-1.78 units on a scale Standard Error 0.18	-2.12 units on a scale Standard Error 0.18	-2.79 units on a scale Standard Error 0.18

SECONDARY outcome

Timeframe: Baseline to Week 16

The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.

Outcome measures

Outcome measures
Measure	Pooled Placebo n=204 Participants This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	Pooled MT-5547 1 mg q4w n=203 Participants This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment Placebo n=165 Participants Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.	After the Amendment MT-5547 1 mg q8w n=162 Participants This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment MT-5547 1 mg q4w n=165 Participants Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48. These participants were included in the pooled MT-5547 1mg q4w group.
WOMAC Physical Function Score (Change From Baseline at Week 16)	-1.38 units on a scale Standard Error 0.16	-2.64 units on a scale Standard Error 0.16	-1.44 units on a scale Standard Error 0.17	-1.88 units on a scale Standard Error 0.17	-2.53 units on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: Baseline to Week 68

Population: Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.

Outcome measures

Outcome measures
Measure	Pooled Placebo n=204 Participants This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	Pooled MT-5547 1 mg q4w n=203 Participants This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment Placebo n=165 Participants Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.	After the Amendment MT-5547 1 mg q8w n=162 Participants This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment MT-5547 1 mg q4w n=165 Participants Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48. These participants were included in the pooled MT-5547 1mg q4w group.
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 1	-0.63 units on a scale Standard Error 0.14	-1.52 units on a scale Standard Error 0.14	-0.58 units on a scale Standard Error 0.14	-1.22 units on a scale Standard Error 0.15	-1.40 units on a scale Standard Error 0.14
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 2	-0.80 units on a scale Standard Error 0.15	-1.80 units on a scale Standard Error 0.15	-0.78 units on a scale Standard Error 0.15	-1.55 units on a scale Standard Error 0.15	-1.65 units on a scale Standard Error 0.15
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 8	-1.29 units on a scale Standard Error 0.16	-2.65 units on a scale Standard Error 0.16	-1.26 units on a scale Standard Error 0.17	-1.76 units on a scale Standard Error 0.17	-2.45 units on a scale Standard Error 0.17
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 12	-1.62 units on a scale Standard Error 0.17	-2.77 units on a scale Standard Error 0.17	-1.61 units on a scale Standard Error 0.18	-2.27 units on a scale Standard Error 0.18	-2.56 units on a scale Standard Error 0.18
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 16	-1.75 units on a scale Standard Error 0.17	-2.97 units on a scale Standard Error 0.17	-1.76 units on a scale Standard Error 0.18	-2.10 units on a scale Standard Error 0.18	-2.77 units on a scale Standard Error 0.18
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 20	-2.43 units on a scale Standard Error 0.17	-3.06 units on a scale Standard Error 0.17	-2.38 units on a scale Standard Error 0.18	-2.54 units on a scale Standard Error 0.18	-2.85 units on a scale Standard Error 0.18
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 24	-2.54 units on a scale Standard Error 0.18	-3.04 units on a scale Standard Error 0.18	-2.52 units on a scale Standard Error 0.18	-2.39 units on a scale Standard Error 0.18	-2.90 units on a scale Standard Error 0.19
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 28	-2.50 units on a scale Standard Error 0.18	-3.19 units on a scale Standard Error 0.18	-2.48 units on a scale Standard Error 0.18	-2.83 units on a scale Standard Error 0.18	-3.05 units on a scale Standard Error 0.18
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 32	-2.62 units on a scale Standard Error 0.18	-3.29 units on a scale Standard Error 0.18	-2.63 units on a scale Standard Error 0.18	-2.60 units on a scale Standard Error 0.18	-3.13 units on a scale Standard Error 0.18
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 36	-2.66 units on a scale Standard Error 0.18	-3.16 units on a scale Standard Error 0.18	-2.72 units on a scale Standard Error 0.18	-2.84 units on a scale Standard Error 0.18	-2.99 units on a scale Standard Error 0.18
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 40	-2.68 units on a scale Standard Error 0.18	-3.28 units on a scale Standard Error 0.18	-2.70 units on a scale Standard Error 0.19	-2.74 units on a scale Standard Error 0.19	-3.08 units on a scale Standard Error 0.19
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 44	-2.72 units on a scale Standard Error 0.18	-3.25 units on a scale Standard Error 0.18	-2.74 units on a scale Standard Error 0.18	-3.03 units on a scale Standard Error 0.18	-3.03 units on a scale Standard Error 0.19
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 48	-2.75 units on a scale Standard Error 0.19	-3.17 units on a scale Standard Error 0.19	-2.75 units on a scale Standard Error 0.19	-2.77 units on a scale Standard Error 0.19	-2.99 units on a scale Standard Error 0.19
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 52	-2.35 units on a scale Standard Error 0.19	-2.80 units on a scale Standard Error 0.20	-2.43 units on a scale Standard Error 0.20	-2.42 units on a scale Standard Error 0.20	-2.56 units on a scale Standard Error 0.20
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 60	-2.53 units on a scale Standard Error 0.20	-2.02 units on a scale Standard Error 0.20	-2.61 units on a scale Standard Error 0.21	-2.32 units on a scale Standard Error 0.21	-1.78 units on a scale Standard Error 0.21
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 68	-2.49 units on a scale Standard Error 0.20	-2.05 units on a scale Standard Error 0.21	-2.60 units on a scale Standard Error 0.20	-2.38 units on a scale Standard Error 0.20	-1.84 units on a scale Standard Error 0.21
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point) Week 4	-1.03 units on a scale Standard Error 0.15	-2.10 units on a scale Standard Error 0.16	-0.98 units on a scale Standard Error 0.16	-1.68 units on a scale Standard Error 0.16	-1.90 units on a scale Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline to Week 68

Population: Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.

Outcome measures

Outcome measures
Measure	Pooled Placebo n=204 Participants This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	Pooled MT-5547 1 mg q4w n=203 Participants This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment Placebo n=165 Participants Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.	After the Amendment MT-5547 1 mg q8w n=162 Participants This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment MT-5547 1 mg q4w n=165 Participants Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48. These participants were included in the pooled MT-5547 1mg q4w group.
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 1	-0.44 units on a scale Standard Error 0.14	-1.23 units on a scale Standard Error 0.14	-0.4 units on a scale Standard Error 0.14	-0.98 units on a scale Standard Error 0.14	-1.12 units on a scale Standard Error 0.14
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 2	-0.56 units on a scale Standard Error 0.14	-1.55 units on a scale Standard Error 0.14	-0.52 units on a scale Standard Error 0.14	-1.25 units on a scale Standard Error 0.14	-1.41 units on a scale Standard Error 0.14
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 4	-0.73 units on a scale Standard Error 0.15	-1.81 units on a scale Standard Error 0.15	-0.71 units on a scale Standard Error 0.15	-1.38 units on a scale Standard Error 0.15	-1.64 units on a scale Standard Error 0.15
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 8	-0.97 units on a scale Standard Error 0.15	-2.34 units on a scale Standard Error 0.16	-0.94 units on a scale Standard Error 0.16	-1.48 units on a scale Standard Error 0.16	-2.17 units on a scale Standard Error 0.16
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 12	-1.26 units on a scale Standard Error 0.16	-2.43 units on a scale Standard Error 0.16	-1.22 units on a scale Standard Error 0.17	-1.94 units on a scale Standard Error 0.17	-2.23 units on a scale Standard Error 0.17
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 16	-1.40 units on a scale Standard Error 0.16	-2.66 units on a scale Standard Error 0.16	-1.40 units on a scale Standard Error 0.17	-1.84 units on a scale Standard Error 0.17	-2.49 units on a scale Standard Error 0.17
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 20	-2.02 units on a scale Standard Error 0.16	-2.74 units on a scale Standard Error 0.16	-1.95 units on a scale Standard Error 0.17	-2.20 units on a scale Standard Error 0.17	-2.53 units on a scale Standard Error 0.17
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 24	-2.22 units on a scale Standard Error 0.17	-2.74 units on a scale Standard Error 0.17	-2.17 units on a scale Standard Error 0.18	-2.02 units on a scale Standard Error 0.18	-2.61 units on a scale Standard Error 0.18
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 28	-2.18 units on a scale Standard Error 0.17	-2.90 units on a scale Standard Error 0.17	-2.15 units on a scale Standard Error 0.17	-2.41 units on a scale Standard Error 0.17	-2.76 units on a scale Standard Error 0.17
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 32	-2.22 units on a scale Standard Error 0.17	-3.00 units on a scale Standard Error 0.17	-2.23 units on a scale Standard Error 0.17	-2.23 units on a scale Standard Error 0.17	-2.83 units on a scale Standard Error 0.17
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 36	-2.31 units on a scale Standard Error 0.17	-2.84 units on a scale Standard Error 0.17	-2.33 units on a scale Standard Error 0.17	-2.47 units on a scale Standard Error 0.17	-2.67 units on a scale Standard Error 0.17
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 40	-2.29 units on a scale Standard Error 0.17	-2.91 units on a scale Standard Error 0.17	-2.29 units on a scale Standard Error 0.18	-2.46 units on a scale Standard Error 0.18	-2.71 units on a scale Standard Error 0.18
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 44	-2.35 units on a scale Standard Error 0.17	-2.90 units on a scale Standard Error 0.17	-2.37 units on a scale Standard Error 0.17	-2.67 units on a scale Standard Error 0.18	-2.69 units on a scale Standard Error 0.18
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 48	-2.38 units on a scale Standard Error 0.18	-2.83 units on a scale Standard Error 0.18	-2.35 units on a scale Standard Error 0.18	-2.46 units on a scale Standard Error 0.18	-2.61 units on a scale Standard Error 0.18
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 52	-2.03 units on a scale Standard Error 0.18	-2.51 units on a scale Standard Error 0.19	-2.06 units on a scale Standard Error 0.19	-2.10 units on a scale Standard Error 0.19	-2.26 units on a scale Standard Error 0.19
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 60	-2.18 units on a scale Standard Error 0.19	-1.75 units on a scale Standard Error 0.19	-2.22 units on a scale Standard Error 0.20	-1.98 units on a scale Standard Error 0.20	-1.52 units on a scale Standard Error 0.20
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point) Week 68	-2.14 units on a scale Standard Error 0.19	-1.71 units on a scale Standard Error 0.20	-2.22 units on a scale Standard Error 0.20	-2.10 units on a scale Standard Error 0.20	-1.51 units on a scale Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline to Week 68

Population: Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.

The WOMAC stiffness subscale score was defined as the average of 2 items(after first waking and later in the day). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where higher scores indicated worse stiffness.

Outcome measures

Outcome measures
Measure	Pooled Placebo n=204 Participants This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	Pooled MT-5547 1 mg q4w n=203 Participants This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment Placebo n=165 Participants Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.	After the Amendment MT-5547 1 mg q8w n=162 Participants This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment MT-5547 1 mg q4w n=165 Participants Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48. These participants were included in the pooled MT-5547 1mg q4w group.
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 1	-0.24 units on a scale Standard Error 0.15	-1.21 units on a scale Standard Error 0.15	-0.24 units on a scale Standard Error 0.15	-0.97 units on a scale Standard Error 0.15	-1.21 units on a scale Standard Error 0.15
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 2	-0.42 units on a scale Standard Error 0.16	-1.55 units on a scale Standard Error 0.16	-0.45 units on a scale Standard Error 0.16	-1.26 units on a scale Standard Error 0.16	-1.56 units on a scale Standard Error 0.16
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 4	-0.58 units on a scale Standard Error 0.16	-1.78 units on a scale Standard Error 0.16	-0.62 units on a scale Standard Error 0.17	-1.37 units on a scale Standard Error 0.17	-1.73 units on a scale Standard Error 0.17
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 8	-0.72 units on a scale Standard Error 0.17	-2.29 units on a scale Standard Error 0.17	-0.75 units on a scale Standard Error 0.17	-1.47 units on a scale Standard Error 0.18	-2.24 units on a scale Standard Error 0.18
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 12	-0.99 units on a scale Standard Error 0.17	-2.36 units on a scale Standard Error 0.18	-1.01 units on a scale Standard Error 0.18	-1.94 units on a scale Standard Error 0.18	-2.30 units on a scale Standard Error 0.18
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 16	-1.21 units on a scale Standard Error 0.17	-2.63 units on a scale Standard Error 0.18	-1.24 units on a scale Standard Error 0.18	-1.78 units on a scale Standard Error 0.18	-2.58 units on a scale Standard Error 0.18
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 20	-1.93 units on a scale Standard Error 0.17	-2.74 units on a scale Standard Error 0.18	-1.95 units on a scale Standard Error 0.18	-2.21 units on a scale Standard Error 0.18	-2.65 units on a scale Standard Error 0.18
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 24	-2.13 units on a scale Standard Error 0.17	-2.80 units on a scale Standard Error 0.18	-2.16 units on a scale Standard Error 0.18	-1.86 units on a scale Standard Error 0.18	-2.74 units on a scale Standard Error 0.19
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 28	-2.02 units on a scale Standard Error 0.17	-2.96 units on a scale Standard Error 0.18	-2.01 units on a scale Standard Error 0.18	-2.31 units on a scale Standard Error 0.18	-2.89 units on a scale Standard Error 0.18
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 32	-2.22 units on a scale Standard Error 0.18	-2.94 units on a scale Standard Error 0.18	-2.31 units on a scale Standard Error 0.19	-2.19 units on a scale Standard Error 0.19	-2.86 units on a scale Standard Error 0.19
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 36	-2.16 units on a scale Standard Error 0.18	-2.91 units on a scale Standard Error 0.18	-2.23 units on a scale Standard Error 0.18	-2.53 units on a scale Standard Error 0.18	-2.87 units on a scale Standard Error 0.18
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 40	-2.16 units on a scale Standard Error 0.18	-2.97 units on a scale Standard Error 0.18	-2.24 units on a scale Standard Error 0.18	-2.44 units on a scale Standard Error 0.18	-2.92 units on a scale Standard Error 0.18
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 44	-2.29 units on a scale Standard Error 0.18	-3.01 units on a scale Standard Error 0.18	-2.38 units on a scale Standard Error 0.18	-2.56 units on a scale Standard Error 0.18	-2.93 units on a scale Standard Error 0.18
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 52	-1.83 units on a scale Standard Error 0.20	-2.51 units on a scale Standard Error 0.20	-1.93 units on a scale Standard Error 0.20	-1.98 units on a scale Standard Error 0.20	-2.44 units on a scale Standard Error 0.20
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 68	-2.09 units on a scale Standard Error 0.21	-1.49 units on a scale Standard Error 0.21	-2.23 units on a scale Standard Error 0.21	-1.90 units on a scale Standard Error 0.21	-1.44 units on a scale Standard Error 0.22
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 48	-2.27 units on a scale Standard Error 0.19	-2.87 units on a scale Standard Error 0.19	-2.34 units on a scale Standard Error 0.19	-2.34 units on a scale Standard Error 0.19	-2.81 units on a scale Standard Error 0.19
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point) Week 60	-2.06 units on a scale Standard Error 0.21	-1.51 units on a scale Standard Error 0.21	-2.17 units on a scale Standard Error 0.21	-1.85 units on a scale Standard Error 0.21	-1.45 units on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline to Week 68

Population: Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.

The WOMAC total subscale score was defined as the average of 24 items(5 pain subscale items, 17 physical functioning subscale items, and 2 stiffness subscale items). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where smaller values being better.

Outcome measures

Outcome measures
Measure	Pooled Placebo n=204 Participants This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	Pooled MT-5547 1 mg q4w n=203 Participants This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment Placebo n=165 Participants Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.	After the Amendment MT-5547 1 mg q8w n=162 Participants This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment MT-5547 1 mg q4w n=165 Participants Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48. These participants were included in the pooled MT-5547 1mg q4w group.
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 2	-0.60 units on a scale Standard Error 0.14	-1.60 units on a scale Standard Error 0.14	-0.56 units on a scale Standard Error 0.14	-1.31 units on a scale Standard Error 0.14	-1.47 units on a scale Standard Error 0.14
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 12	-1.31 units on a scale Standard Error 0.16	-2.49 units on a scale Standard Error 0.16	-1.28 units on a scale Standard Error 0.17	-2.01 units on a scale Standard Error 0.17	-2.31 units on a scale Standard Error 0.17
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 16	-1.46 units on a scale Standard Error 0.16	-2.72 units on a scale Standard Error 0.16	-1.45 units on a scale Standard Error 0.17	-1.89 units on a scale Standard Error 0.17	-2.56 units on a scale Standard Error 0.17
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 20	-2.10 units on a scale Standard Error 0.16	-2.81 units on a scale Standard Error 0.16	-2.03 units on a scale Standard Error 0.17	-2.27 units on a scale Standard Error 0.17	-2.60 units on a scale Standard Error 0.17
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 24	-2.28 units on a scale Standard Error 0.17	-2.81 units on a scale Standard Error 0.17	-2.24 units on a scale Standard Error 0.17	-2.08 units on a scale Standard Error 0.17	-2.68 units on a scale Standard Error 0.18
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 28	-2.23 units on a scale Standard Error 0.16	-2.97 units on a scale Standard Error 0.17	-2.20 units on a scale Standard Error 0.17	-2.49 units on a scale Standard Error 0.17	-2.83 units on a scale Standard Error 0.17
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 32	-2.30 units on a scale Standard Error 0.17	-3.06 units on a scale Standard Error 0.17	-2.31 units on a scale Standard Error 0.17	-2.30 units on a scale Standard Error 0.17	-2.89 units on a scale Standard Error 0.17
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 36	-2.37 units on a scale Standard Error 0.17	-2.91 units on a scale Standard Error 0.17	-2.39 units on a scale Standard Error 0.17	-2.55 units on a scale Standard Error 0.17	-2.75 units on a scale Standard Error 0.17
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 40	-2.36 units on a scale Standard Error 0.17	-2.99 units on a scale Standard Error 0.17	-2.36 units on a scale Standard Error 0.17	-2.51 units on a scale Standard Error 0.18	-2.80 units on a scale Standard Error 0.18
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 44	-2.42 units on a scale Standard Error 0.17	-2.98 units on a scale Standard Error 0.17	-2.44 units on a scale Standard Error 0.17	-2.73 units on a scale Standard Error 0.17	-2.78 units on a scale Standard Error 0.17
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 60	-2.24 units on a scale Standard Error 0.19	-1.79 units on a scale Standard Error 0.19	-2.29 units on a scale Standard Error 0.20	-2.04 units on a scale Standard Error 0.20	-1.57 units on a scale Standard Error 0.20
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 68	-2.20 units on a scale Standard Error 0.19	-1.76 units on a scale Standard Error 0.19	-2.29 units on a scale Standard Error 0.20	-2.14 units on a scale Standard Error 0.20	-1.57 units on a scale Standard Error 0.20
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 1	-0.46 units on a scale Standard Error 0.13	-1.29 units on a scale Standard Error 0.13	-0.42 units on a scale Standard Error 0.13	-1.03 units on a scale Standard Error 0.14	-1.18 units on a scale Standard Error 0.13
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 4	-0.78 units on a scale Standard Error 0.14	-1.87 units on a scale Standard Error 0.15	-0.75 units on a scale Standard Error 0.15	-1.44 units on a scale Standard Error 0.15	-1.70 units on a scale Standard Error 0.15
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 8	-1.02 units on a scale Standard Error 0.15	-2.40 units on a scale Standard Error 0.15	-0.98 units on a scale Standard Error 0.15	-1.54 units on a scale Standard Error 0.16	-2.23 units on a scale Standard Error 0.15
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 48	-2.45 units on a scale Standard Error 0.17	-2.91 units on a scale Standard Error 0.18	-2.42 units on a scale Standard Error 0.18	-2.51 units on a scale Standard Error 0.18	-2.70 units on a scale Standard Error 0.18
WOMAC Total Score (Change From Baseline at Each Assessment Time Point) Week 52	-2.08 units on a scale Standard Error 0.18	-2.57 units on a scale Standard Error 0.18	-2.11 units on a scale Standard Error 0.19	-2.15 units on a scale Standard Error 0.19	-2.33 units on a scale Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline to Week 68

Population: Analysis was performed on modified FAS(mFAS). For the analysis of After amendment MT-5547 1 mg ｑ8w group comparing to placebo group and MT-5547 1 mg q4w group, after the protocol amendment randomized populations are also presented. This study produced 16-week, 24-week, and 68-week treatment period datasets. The results in this section are presented in the 68-week treatment period dataset. Here 'n' = Number of evaluable participants at the specified point in time.

Patient Global Assessment(PGA) was a measure whereby the participant assessed global improvement in OA using the 5-level scale(1=very well; 2=well; 3=fair; 4=poor; and 5=very poor).

Outcome measures

Outcome measures
Measure	Pooled Placebo n=204 Participants This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	Pooled MT-5547 1 mg q4w n=203 Participants This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment Placebo n=165 Participants Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.	After the Amendment MT-5547 1 mg q8w n=162 Participants This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment MT-5547 1 mg q4w n=165 Participants Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48. These participants were included in the pooled MT-5547 1mg q4w group.
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 24	-1.2 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 32	-1.1 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.0 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 36	-1.2 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 44	-1.2 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 48	-1.1 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 4	-0.5 units on a scale Standard Error 0.1	-1.0 units on a scale Standard Error 0.1	-0.5 units on a scale Standard Error 0.1	-0.9 units on a scale Standard Error 0.1	-1.0 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 8	-0.6 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1	-0.7 units on a scale Standard Error 0.1	-0.9 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 12	-0.8 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-0.8 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 52	-0.9 units on a scale Standard Error 0.1	-0.9 units on a scale Standard Error 0.1	-0.9 units on a scale Standard Error 0.1	-0.9 units on a scale Standard Error 0.1	-0.9 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 60	-0.9 units on a scale Standard Error 0.1	-0.5 units on a scale Standard Error 0.1	-1.0 units on a scale Standard Error 0.1	-0.8 units on a scale Standard Error 0.1	-0.5 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 68	-0.9 units on a scale Standard Error 0.1	-0.5 units on a scale Standard Error 0.1	-1.0 units on a scale Standard Error 0.1	-0.8 units on a scale Standard Error 0.1	-0.6 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 20	-1.1 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 28	-1.0 units on a scale Standard Error 0.1	-1.3 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1	-1.3 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 40	-1.1 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.0 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 16	-0.8 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1	-0.9 units on a scale Standard Error 0.1	-1.1 units on a scale Standard Error 0.1	-1.2 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 2	-0.5 units on a scale Standard Error 0.1	-0.8 units on a scale Standard Error 0.1	-0.5 units on a scale Standard Error 0.1	-0.9 units on a scale Standard Error 0.1	-0.8 units on a scale Standard Error 0.1
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point) Week 1	-0.3 units on a scale Standard Error 0.1	-0.7 units on a scale Standard Error 0.1	-0.4 units on a scale Standard Error 0.1	-0.7 units on a scale Standard Error 0.1	-0.7 units on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks)

Population: The analysis was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available

Outcome measures

Outcome measures
Measure	Pooled Placebo n=204 Participants This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	Pooled MT-5547 1 mg q4w n=162 Participants This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment Placebo n=203 Participants Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.	After the Amendment MT-5547 1 mg q8w n=28 Participants This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment MT-5547 1 mg q4w n=29 Participants Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48. These participants were included in the pooled MT-5547 1mg q4w group.
Number of Participants With Adverse Events and Adverse Drug Reactions Participants with at least one adverse drug reaction (treatment period)	14 Participants	20 Participants	25 Participants	1 Participants	3 Participants
Number of Participants With Adverse Events and Adverse Drug Reactions Participants with at least one AE (post-treatment period)	115 Participants	83 Participants	117 Participants	19 Participants	16 Participants
Number of Participants With Adverse Events and Adverse Drug Reactions Participants with at least one AE (Treatment Period)	174 Participants	136 Participants	168 Participants	11 Participants	14 Participants
Number of Participants With Adverse Events and Adverse Drug Reactions Participants with at least one adverse drug reaction (post-treatment period)	3 Participants	4 Participants	14 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline to Week 68

All the Joint Replacement surgeries that were performed within 20 weeks from the day after the end date of the treatment period were reported and tabulated in this study in order to assess the outcome of joint damage regardless of the presence or absence of related adjudicated arthropathy. The subjects who were going to undergo JR surgery were to be withdrawn from study treatment.

Outcome measures

Outcome measures
Measure	Pooled Placebo n=204 Participants This group consists of total of 204 participants who were randomized to Placebo group before (N=39) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	Pooled MT-5547 1 mg q4w n=162 Participants This group consists of total 203 participants who were randomized to MT-5547 1 mg q4w group before (N=38) and after (N=165) the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment Placebo n=203 Participants Participants in this group were randomized to Placebo group after the protocol amendment. Participants randomized to this group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48. These participants were included in the Pooled Placebo group.	After the Amendment MT-5547 1 mg q8w n=28 Participants This group was added after Protocol Amendment. Participants randomized to this group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	After the Amendment MT-5547 1 mg q4w n=29 Participants Participants in this group were randomized to MT-5547 1mg q4w group after the protocol amendment. Participants randomized to this group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48. These participants were included in the pooled MT-5547 1mg q4w group.
Number of Participants With a Joint Replacement Procedure is Scheduled	4 Participants	5 Participants	10 Participants	1 Participants	0 Participants

Adverse Events

Placebo, On-treatment Period

Serious events: 6 serious events

Other events: 108 other events

Deaths: 0 deaths

MT-5547 1 mg q8w, On-treatment Period

Serious events: 4 serious events

Other events: 85 other events

Deaths: 0 deaths

MT-5547 1mg q4w, On-treatment Period

Serious events: 9 serious events

Other events: 118 other events

Deaths: 0 deaths

MT-5547 3 mg q4w, On-treatment Period

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

MT-5547 6 mg q8w, On-treatment Period

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo, Post-treatment Observation Period

Serious events: 5 serious events

Other events: 51 other events

Deaths: 0 deaths

MT-5547 1 mg q8w, Post-treatment Observation Period

Serious events: 3 serious events

Other events: 37 other events

Deaths: 0 deaths

MMT-5547 1mg q4w, Post-treatment Observation Period

Serious events: 7 serious events

Other events: 65 other events

Deaths: 0 deaths

MT-5547 3 mg q4w, Post-treatment Observation Period

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

MT-5547 6 mg q8w, Post-treatment Observation Period

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo, On-treatment Period n=204 participants at risk Placebo group is the same population as the Pooled Placebo group. Participants randomized to the Placebo group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	MT-5547 1 mg q8w, On-treatment Period n=162 participants at risk MT-5547 1mg q8w group is the same population as the After amendment MT-5547 1mg q8w. Participants randomized to the After the amendment MT-5547 1 mg q8w group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 1mg q4w, On-treatment Period n=203 participants at risk MT-5547 1mg q4w group is the same population as the Pooled MT-5547 1mg q4w. Participants randomized to the Pooled MT-5547 1mg q4w group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 3 mg q4w, On-treatment Period n=28 participants at risk Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 6 mg q8w, On-treatment Period n=29 participants at risk Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	Placebo, Post-treatment Observation Period n=204 participants at risk Placebo group is the same population as the Pooled Placebo group. Participants randomized to the Placebo group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	MT-5547 1 mg q8w, Post-treatment Observation Period n=162 participants at risk MT-5547 1mg q8w group is the same population as the After amendment MT-5547 1mg q8w. Participants randomized to the After the amendment MT-5547 1 mg q8w group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MMT-5547 1mg q4w, Post-treatment Observation Period n=203 participants at risk MT-5547 1mg q4w group is the same population as the Pooled MT-5547 1mg q4w. Participants randomized to the Pooled MT-5547 1mg q4w group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 3 mg q4w, Post-treatment Observation Period n=28 participants at risk Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 6 mg q8w, Post-treatment Observation Period n=29 participants at risk Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.
Eye disorders Cataract	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Gastrointestinal disorders Colitis ischaemic	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Gastrointestinal disorders Large intestine polyp	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
General disorders Pyrexia	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Hepatobiliary disorders Cholecystitis	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Infections and infestations Cellulitis	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Infections and infestations Chronic sinusitis	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Infections and infestations Encephalitis viral	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Infections and infestations Pneumonia bacterial	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.98% 2/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Injury, poisoning and procedural complications Femur fracture	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Injury, poisoning and procedural complications Heat illness	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.62% 1/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.62% 1/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.6% 1/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.62% 1/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Rapidly progressive osteoarthritis	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.6% 1/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.62% 1/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.62% 1/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.4% 1/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.62% 1/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.4% 1/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Nervous system disorders Cerebral infarction	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Nervous system disorders Corticobasal degeneration	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.62% 1/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Nervous system disorders Syncope	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.6% 1/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.4% 1/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.62% 1/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.

Other adverse events

Other adverse events
Measure	Placebo, On-treatment Period n=204 participants at risk Placebo group is the same population as the Pooled Placebo group. Participants randomized to the Placebo group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	MT-5547 1 mg q8w, On-treatment Period n=162 participants at risk MT-5547 1mg q8w group is the same population as the After amendment MT-5547 1mg q8w. Participants randomized to the After the amendment MT-5547 1 mg q8w group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 1mg q4w, On-treatment Period n=203 participants at risk MT-5547 1mg q4w group is the same population as the Pooled MT-5547 1mg q4w. Participants randomized to the Pooled MT-5547 1mg q4w group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 3 mg q4w, On-treatment Period n=28 participants at risk Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 6 mg q8w, On-treatment Period n=29 participants at risk Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	Placebo, Post-treatment Observation Period n=204 participants at risk Placebo group is the same population as the Pooled Placebo group. Participants randomized to the Placebo group received MT-5547-matching placebo SC q4w from Week 0 to Week 44. Naproxen oral was received from the day after the Week 16 until Week 48.	MT-5547 1 mg q8w, Post-treatment Observation Period n=162 participants at risk MT-5547 1mg q8w group is the same population as the After amendment MT-5547 1mg q8w. Participants randomized to the After the amendment MT-5547 1 mg q8w group received MT-5547 1 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MMT-5547 1mg q4w, Post-treatment Observation Period n=203 participants at risk MT-5547 1mg q4w group is the same population as the Pooled MT-5547 1mg q4w. Participants randomized to the Pooled MT-5547 1mg q4w group received MT-5547 1 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 3 mg q4w, Post-treatment Observation Period n=28 participants at risk Participants randomized to the MT-5547 3 mg q4w group received MT-5547 3 mg SC q4w from Week 0 to Week 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.	MT-5547 6 mg q8w, Post-treatment Observation Period n=29 participants at risk Participants randomized to the After the amendment MT-5547 6 mg q8w group received MT-5547 6 mg SC on Weeks 0, 8, 16, 24, 32, and 40, and MT-5547-matching placebo SC on Weeks 4, 12, 20, 28, 36, and 44. Naproxen-matching placebo oral was received from the day after the Week 16 until Week 48.
Eye disorders Cataract	1.5% 3/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	2.0% 4/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.98% 2/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	7.1% 2/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Gastrointestinal disorders Stomatitis	2.9% 6/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	1.2% 2/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.99% 2/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.4% 1/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	1.2% 2/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	7.1% 2/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Infections and infestations Nasopharyngitis	28.9% 59/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	30.2% 49/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	30.5% 62/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	7.1% 2/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	13.8% 4/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	12.3% 25/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	7.4% 12/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	6.9% 14/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	7.1% 2/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.4% 1/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Injury, poisoning and procedural complications Contusion	8.3% 17/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	5.6% 9/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	5.9% 12/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	6.9% 2/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.98% 2/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.1% 5/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	1.5% 3/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 6/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	4.9% 8/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	8.4% 17/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.9% 8/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	1.2% 2/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.4% 7/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	10.7% 3/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.4% 1/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Back pain	8.3% 17/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	8.6% 14/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	8.4% 17/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.4% 7/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	1.2% 2/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	2.0% 4/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.6% 1/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	2.5% 5/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	2.5% 4/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	1.5% 3/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	7.1% 2/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.62% 1/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	2.5% 5/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.4% 11/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	4.9% 10/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.62% 1/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.6% 1/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Periarthritis	2.5% 5/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	1.9% 3/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	2.5% 5/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	2.5% 5/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	4.3% 7/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	5.4% 11/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Rapidly progressive osteoarthritis	0.98% 2/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	4.3% 7/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	9.9% 20/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.4% 1/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	2.5% 4/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	8.4% 17/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	7.1% 2/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	6.9% 2/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Tendonitis	0.98% 2/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	1.2% 2/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.99% 2/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.99% 2/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	6.9% 2/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.98% 2/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	6.9% 2/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.62% 1/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	2.0% 4/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Nervous system disorders Carpal tunnel syndrome	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	1.9% 3/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	3.9% 8/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	6.9% 2/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Nervous system disorders Headache	11.3% 23/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	9.3% 15/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	7.9% 16/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.98% 2/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	1.2% 2/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	2.0% 4/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.
Nervous system disorders Somnolence	0.98% 2/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.62% 1/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.49% 1/204 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	1.2% 2/162 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.99% 2/203 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	0.00% 0/28 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.	6.9% 2/29 • Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks) The analysis of safety was performed in the safety analysis set (SAF). The SAF consisted of all randomized participants except for the following participants * participants who did not receive study drug even once * participants for whom absolutely no post-randomization safety data are available Reported AEs \& deaths are treatment emergent.

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

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Email: [email protected]

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Principal investigator is a sponsor employee
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