Trial Outcomes & Findings for An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis (NCT NCT00723528)

NCT ID: NCT00723528

Last Updated: 2014-05-20

Results Overview

Percentage of participants with \>=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 158 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2014-05-20

Participant Flow

Participant milestones

Measure	Placebo (CP) Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Placebo A (After CP) After the controlled period (that is \[i.e.\], during the active drug treatment period \[Weeks 12-64\]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.	Placebo B (After CP) After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.	Ustekinumab 45 mg (After CP) After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.	Ustekinumab 90 mg (After CP) After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
Period 1: Controlled Period (CP) STARTED	32	64	62	0	0	0	0
Period 1: Controlled Period (CP) COMPLETED	28	64	58	0	0	0	0
Period 1: Controlled Period (CP) NOT COMPLETED	4	0	4	0	0	0	0
Period 2: After Controlled Period STARTED	0	0	0	15	13	64	58
Period 2: After Controlled Period COMPLETED	0	0	0	14	11	58	54
Period 2: After Controlled Period NOT COMPLETED	0	0	0	1	2	6	4

Reasons for withdrawal

Measure	Placebo (CP) Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Placebo A (After CP) After the controlled period (that is \[i.e.\], during the active drug treatment period \[Weeks 12-64\]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.	Placebo B (After CP) After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.	Ustekinumab 45 mg (After CP) After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.	Ustekinumab 90 mg (After CP) After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52. Participants were then followed until Week 72.
Period 1: Controlled Period (CP) Adverse Event	0	0	1	0	0	0	0
Period 1: Controlled Period (CP) Withdrawal by Subject	2	0	0	0	0	0	0
Period 1: Controlled Period (CP) Physician Decision	0	0	1	0	0	0	0
Period 1: Controlled Period (CP) Onset of Tuberculosis Infection	0	0	1	0	0	0	0
Period 1: Controlled Period (CP) Withdrawal due to worsened symptoms	2	0	1	0	0	0	0
Period 2: After Controlled Period Withdrawal by Subject	0	0	0	1	0	1	1
Period 2: After Controlled Period Onset of tuberculosis infection	0	0	0	0	0	1	0
Period 2: After Controlled Period Other	0	0	0	0	1	4	0
Period 2: After Controlled Period Adverse Event	0	0	0	0	1	0	1
Period 2: After Controlled Period Use of prohibited concomitant medication	0	0	0	0	0	0	1
Period 2: After Controlled Period Withdrawal due to worsened symptoms	0	0	0	0	0	0	1

Baseline Characteristics

An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis

Baseline characteristics by cohort

Measure	Placebo (CP) n=31 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=64 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=62 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Total n=157 Participants Total of all reporting groups
Age, Continuous	48.5 Years STANDARD_DEVIATION 12.7 • n=5 Participants	46.6 Years STANDARD_DEVIATION 12.5 • n=7 Participants	46.8 Years STANDARD_DEVIATION 12.8 • n=5 Participants	47.0 Years STANDARD_DEVIATION 12.6 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants	31 Participants n=4 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	53 Participants n=7 Participants	47 Participants n=5 Participants	126 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 12

Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.

Percentage of participants with >=75% improvement in PASI score at Week 12 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Baseline visit refers to Week 0.

Outcome measures

Measure	Placebo (CP) n=31 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=64 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=62 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (After CP) After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Percentage of Participants With Greater Than or Equal to 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score	6.5 Percentage of participants	59.4 Percentage of participants	67.7 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 12

Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. "N" (number of participants analyzed) signifies the participants evaluable for this measure.

The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).

Outcome measures

Measure	Placebo (CP) n=31 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=62 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=61 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (After CP) After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12	-0.3 Units on scale Standard Deviation 5.25	-8.0 Units on scale Standard Deviation 6.45	-7.4 Units on scale Standard Deviation 6.52	—

SECONDARY outcome

Timeframe: Week 64

Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.

PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).

Outcome measures

Measure	Placebo (CP) n=15 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=14 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=60 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (After CP) n=56 Participants After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Psoriasis Area and Severity Index (PASI) Score	10.83 Units on a scale Standard Deviation 16.149	8.29 Units on a scale Standard Deviation 9.975	6.60 Units on a scale Standard Deviation 9.060	4.94 Units on a scale Standard Deviation 7.493

SECONDARY outcome

Timeframe: Week 64

Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure.

PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.

Outcome measures

Measure	Placebo (CP) n=15 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=14 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=60 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (After CP) n=56 Participants After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Percentage of Treatment Response Based on Psoriasis Area and Severity Index (PASI) Score	70.78 Percentage of treatment response Standard Deviation 38.816	63.07 Percentage of treatment response Standard Deviation 43.608	78.86 Percentage of treatment response Standard Deviation 25.910	82.36 Percentage of treatment response Standard Deviation 26.798

SECONDARY outcome

Timeframe: Week 64

Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.

PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst). Percentage of Treatment Response= (Baseline PASI score-PASI score after treatment)/Baseline PASI score x 100. Baseline visit refers to Week 0.

Outcome measures

Measure	Placebo (CP) n=15 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=14 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=60 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (After CP) n=56 Participants After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score >= 50% Treatment Response	80 Percentage of participants	71.4 Percentage of participants	91.7 Percentage of participants	89.3 Percentage of participants
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score >= 90% Treatment Response	60 Percentage of participants	50 Percentage of participants	50 Percentage of participants	55.4 Percentage of participants
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%), 90%, and Equal to 100% of Treatment Response Based on PASI Score 100% Treatment Response	13.3 Percentage of participants	21.4 Percentage of participants	18.3 Percentage of participants	17.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 28, 40, 52 and 64

Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here,'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.

The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).

Outcome measures

Measure	Placebo (CP) n=15 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=15 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=64 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (After CP) n=59 Participants After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 Change at Week 28 (n=15,15,64,59)	-6.4 Unit on scale Standard Deviation 6.74	-6.2 Unit on scale Standard Deviation 6.14	-7.5 Unit on scale Standard Deviation 6.46	-7.6 Unit on scale Standard Deviation 6.59
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 Change at Week 40 (n=15,15,61,56)	-6.5 Unit on scale Standard Deviation 6.46	-6.5 Unit on scale Standard Deviation 6.08	-7.7 Unit on scale Standard Deviation 6.98	-7.9 Unit on scale Standard Deviation 6.62
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 Change at Week 52 (n=15,14,60,57)	-6.3 Unit on scale Standard Deviation 5.92	-5.5 Unit on scale Standard Deviation 6.60	-7.3 Unit on scale Standard Deviation 7.01	-7.8 Unit on scale Standard Deviation 6.96
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 28, 40, 52 and 64 Change at Week 64 (n=15,14,60,56)	-5.8 Unit on scale Standard Deviation 6.05	-5.7 Unit on scale Standard Deviation 6.96	-7.4 Unit on scale Standard Deviation 6.92	-7.9 Unit on scale Standard Deviation 6.43

SECONDARY outcome

Timeframe: Week 12, 28, 40, 52 and 64

Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.

The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: (1) physical component summary (PCS)=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary (MCS)=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both sub scores and summary scores. For sub scores and summary scores: 0=worst score and 100=best score.

Outcome measures

Measure	Placebo (CP) n=15 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=16 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=64 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (After CP) n=61 Participants After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 Change at Week 12: PCS(n=15,16,62,61)	-.88 Unit on scale Standard Deviation 11.141	-1.03 Unit on scale Standard Deviation 8.328	7.76 Unit on scale Standard Deviation 14.536	5.14 Unit on scale Standard Deviation 12.036
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 Change at Week 12: MCS(n=15,16,62,61)	1.16 Unit on scale Standard Deviation 5.263	2.84 Unit on scale Standard Deviation 7.994	5.28 Unit on scale Standard Deviation 9.797	5.77 Unit on scale Standard Deviation 10.450
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 Change at Week 28: PCS(n=15,15,64,59)	2.22 Unit on scale Standard Deviation 15.064	6.42 Unit on scale Standard Deviation 16.113	8.54 Unit on scale Standard Deviation 14.538	6.23 Unit on scale Standard Deviation 11.721
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 Change at Week 28: MCS(n=15,15,64,59)	6.19 Unit on scale Standard Deviation 7.069	3.22 Unit on scale Standard Deviation 6.621	6.84 Unit on scale Standard Deviation 10.086	7.24 Unit on scale Standard Deviation 11.932
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 Change at Week 40: PCS(n=15,15,61,57)	2.12 Unit on scale Standard Deviation 19.683	6.18 Unit on scale Standard Deviation 15.914	8.95 Unit on scale Standard Deviation 15.476	3.58 Unit on scale Standard Deviation 16.339
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 Change at Week 40: MCS(n=15,15,61,57)	4.90 Unit on scale Standard Deviation 5.453	5.27 Unit on scale Standard Deviation 11.303	6.61 Unit on scale Standard Deviation 9.674	8.34 Unit on scale Standard Deviation 10.415
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 Change at Week 52: PCS(n=15,14,60,56)	4.03 Unit on scale Standard Deviation 16.426	6.58 Unit on scale Standard Deviation 16.496	8.33 Unit on scale Standard Deviation 16.365	6.19 Unit on scale Standard Deviation 13.608
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 Change at Week 52: MCS(n=15,14,60,56)	4.44 Unit on scale Standard Deviation 5.198	5.93 Unit on scale Standard Deviation 9.755	5 Unit on scale Standard Deviation 10.386	7.69 Unit on scale Standard Deviation 8.998
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 Change at Week 64: PCS(n=15,14,60,56)	3.79 Unit on scale Standard Deviation 15.519	6.10 Unit on scale Standard Deviation 16.164	8.27 Unit on scale Standard Deviation 15.468	6.70 Unit on scale Standard Deviation 12.990
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Week 12, 28, 40, 52 and 64 Change at Week 64: MCS(n=15,14,60,56)	4.67 Unit on scale Standard Deviation 5.362	5.21 Unit on scale Standard Deviation 7.958	5.11 Unit on scale Standard Deviation 10.504	6.89 Unit on scale Standard Deviation 9.433

SECONDARY outcome

Timeframe: Week 12, 28, 40, 52 and 64

Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.

The PDI questionnaire consists of 15 questions relating to the impact of psoriasis in terms of daily activities, work or school, personal relationships, leisure, and treatment. Each question is scored on a scale of 0 (no impact) to 3 (greatest impact). The PDI is calculated by summing the scores of the questions resulting in a maximum score of 45 (greatest impact) and a minimum score of 0 (no impact).

Outcome measures

Measure	Placebo (CP) n=15 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=16 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=64 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (After CP) n=61 Participants After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 Change at Week 12 (n=15,16,62,61)	0.1 Unit on scale Standard Deviation 3.70	0.1 Unit on scale Standard Deviation 4.76	-8.6 Unit on scale Standard Deviation 9.63	-12.0 Unit on scale Standard Deviation 11.80
Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 Change at Week 28 (n=15,15,64,59)	-10.0 Unit on scale Standard Deviation 9.52	-8.1 Unit on scale Standard Deviation 8.90	-10.8 Unit on scale Standard Deviation 9.45	-13.2 Unit on scale Standard Deviation 10.75
Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 Change at Week 40 (n=15,15,61,57)	-9.4 Unit on scale Standard Deviation 9.07	-8.5 Unit on scale Standard Deviation 9.67	-11.3 Unit on scale Standard Deviation 9.92	-14.0 Unit on scale Standard Deviation 10.53
Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 Change at Week 52 (n=15,14,60,56)	-10.4 Unit on scale Standard Deviation 8.60	-6.5 Unit on scale Standard Deviation 10.86	-10.6 Unit on scale Standard Deviation 9.06	-14.5 Unit on scale Standard Deviation 10.64
Change From Baseline in Psoriasis Disability Index (PDI) Score at Week 12, 28, 40, 52 and 64 Change at Week 64 (n=15,14,60,56)	-10.6 Unit on scale Standard Deviation 9.12	-7.6 Unit on scale Standard Deviation 10.10	-10.7 Unit on scale Standard Deviation 9.71	-14.3 Unit on scale Standard Deviation 10.17

SECONDARY outcome

Timeframe: Week 12, 28, 40,52 and 64

Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.

The NAPSI score is used to evaluate the severity of nail bed psoriasis and nail matrix psoriasis. The nail is divided with into quadrants and given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail is evaluated, and the sum of all the nails is the total NAPSI score. The sum of the scores from all nails ranges from 0 (no psoriasis) to 80 (psoriasis present in all 4 quadrants of all 10 nails).

Outcome measures

Measure	Placebo (CP) n=9 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=8 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=44 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (After CP) n=40 Participants After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score NAPSI Score at Week 12 (n=9,8,43,40)	11.1 Unit on scale Standard Deviation 33.33	6.3 Unit on scale Standard Deviation 17.68	7.7 Unit on scale Standard Deviation 95.14	10.0 Unit on scale Standard Deviation 66.06
Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score NAPSI Score at Week 28 (n=9,7,44,38)	34.9 Unit on scale Standard Deviation 42.17	34.5 Unit on scale Standard Deviation 44.21	52.0 Unit on scale Standard Deviation 39.59	51.6 Unit on scale Standard Deviation 49.97
Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score NAPSI Score at Week 40 (n=9,7,42,36)	31.6 Unit on scale Standard Deviation 40.17	38.1 Unit on scale Standard Deviation 48.80	59.9 Unit on scale Standard Deviation 45.87	61.1 Unit on scale Standard Deviation 53.17
Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score NAPSI Score at Week 52 (n=9,7,42,37)	48.0 Unit on scale Standard Deviation 47.62	38.1 Unit on scale Standard Deviation 48.80	60.0 Unit on scale Standard Deviation 45.96	61.4 Unit on scale Standard Deviation 48.28
Treatment Response Based on Nail Psoriasis Severity Index (NAPSI) Score NAPSI Score at Week 64 (n=9,7,42,36)	51.5 Unit on scale Standard Deviation 45.20	39.3 Unit on scale Standard Deviation 45.32	56.6 Unit on scale Standard Deviation 43.24	67.8 Unit on scale Standard Deviation 37.49

SECONDARY outcome

Timeframe: Week 12, 28, 40, 52 and 64

Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.

The number of nails with psoriasis involvement was assessed by a dermatologist.

Outcome measures

Measure	Placebo (CP) n=15 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=16 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=64 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (After CP) n=61 Participants After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 Change at Week 28 (n=15,15,64,59)	-0.1 Nails Standard Deviation 2.80	-0.1 Nails Standard Deviation 1.13	-1.8 Nails Standard Deviation 2.89	-1.4 Nails Standard Deviation 3.03
Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 Change at Week 12 (n=15,16,62,61)	0.9 Nails Standard Deviation 2.64	-0.1 Nails Standard Deviation 0.25	0 Nails Standard Deviation 1.96	0 Nails Standard Deviation 1.83
Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 Change at Week 40 (n=15,15,61,56)	-1.5 Nails Standard Deviation 2.77	-1.1 Nails Standard Deviation 3.20	-2.6 Nails Standard Deviation 3.18	-1.8 Nails Standard Deviation 3.34
Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 Change at Week 52 (n=15,14,60,57)	-1.8 Nails Standard Deviation 3.23	-1.4 Nails Standard Deviation 3.34	-2.8 Nails Standard Deviation 3.32	-1.92 Nails Standard Deviation 3.36
Change From Baseline in the Number of Nails With Psoriasis Involvement at Week 12, 28, 40, 52 and 64 Change at Week 64 (n=15,14,60,56)	-1.3 Nails Standard Deviation 2.92	-1.1 Nails Standard Deviation 3.32	-2.6 Nails Standard Deviation 3.38	-1.8 Nails Standard Deviation 3.43

SECONDARY outcome

Timeframe: Week 12, 28, 40, 52 and 64

Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure and 'n' signifies the participants evaluated for this measure at a particular time point.

Each participant will assess his/her pain associated with joint symptoms on each assessment day using a 100 mm VAS ranging from 0 mm (no pain) to 100 mm (the worst pain imaginable).

Outcome measures

Measure	Placebo (CP) n=2 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=1 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=6 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (After CP) n=13 Participants After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 Change at Week 12 (n=2,1,6,13)	0.5 Unit on scale Standard Deviation 0.71	23.0 Unit on scale Standard Deviation NA Standard deviation was not estimable because number of participant analyzed for this time point is 1	-38.5 Unit on scale Standard Deviation 28.93	-9.3 Unit on scale Standard Deviation 18.23
Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 Change at Week 28 (n=2,0,6,12)	-8.0 Unit on scale Standard Deviation 11.31	NA Unit on scale Standard Deviation NA No participant was found with joint symptoms for which pain assessment could be conducted for this treatment group	-30.0 Unit on scale Standard Deviation 37.97	-24.8 Unit on scale Standard Deviation 27.17
Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 Change at Week 40 (n=2,0,6,11)	-16.0 Unit on scale Standard Deviation 22.63	NA Unit on scale Standard Deviation NA No participant was found with joint symptoms for which pain assessment could be conducted for this treatment group	-29.3 Unit on scale Standard Deviation 33.17	-30.2 Unit on scale Standard Deviation 25.0
Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 Change at Week 52 (n=2,0,6,11)	-4.0 Unit on scale Standard Deviation 5.66	NA Unit on scale Standard Deviation NA No participant was found with joint symptoms for which pain assessment could be conducted for this treatment group	-35.0 Unit on scale Standard Deviation 35.49	-28.1 Unit on scale Standard Deviation 26.55
Change From Baseline in Joint Symptoms Expressed on a Visual Analogue Scale (VAS) at Week 12, 28, 40, 52 and 64 Change at Week 64 (n=2,0,6,11)	-7.5 Unit on scale Standard Deviation 10.61	NA Unit on scale Standard Deviation NA No participant was found with joint symptoms for which pain assessment could be conducted for this treatment group	-35.3 Unit on scale Standard Deviation 38.55	-27.2 Unit on scale Standard Deviation 28.38

SECONDARY outcome

Timeframe: Week 12

Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication.

Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].

Outcome measures

Measure	Placebo (CP) n=31 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=64 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=62 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (After CP) After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 12	9.7 Percentage of participants	57.8 Percentage of participants	69.4 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 64

Population: The full analysis set (FAS) population included all the randomly assigned participants with efficacy data who fulfilled the eligibility criteria and received study medication. Here, 'N' signifies the participants evaluated for this measure.

Percentage of participants with PGA score of cleared (0), cleared or minimal (0 or 1) and mild (less than or equal to 2) was reported. The PGA score is a numeric scale which is completed by the physician and is designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded for induration (I), erythema (E), and scaling (S) as: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=marked, and 5=severe. The sum of the 3 scores (I + E + S) will be divided by 3 to obtain a final PGA score ranging from 0 [best] to 5 [worst].

Outcome measures

Measure	Placebo (CP) n=15 Participants Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=14 Participants Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=60 Participants Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (After CP) n=56 Participants After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 PGA score= 0 (cleared)	13.3 Percentage of participants	21.4 Percentage of participants	21.7 Percentage of participants	28.6 Percentage of participants
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 PGA score= 0 or 1 (minimal)	53.3 Percentage of participants	71.4 Percentage of participants	53.3 Percentage of participants	69.6 Percentage of participants
Percentage of Participants With Cleared (0), Cleared or Minimal (0 or 1) and Mild (Less Than or Equal to 2) Physician's Global Assessment (PGA) Score at Week 64 PGA score= 0, 1 or 2 (mild)	73.3 Percentage of participants	71.4 Percentage of participants	83.3 Percentage of participants	82.1 Percentage of participants

Adverse Events

Placebo (CP)

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Ustekinumab 45 mg (CP)

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Ustekinumab 90 mg (CP)

Serious events: 3 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo A (After CP)

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo B (After CP)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Ustekinumab 45 mg (After CP)

Serious events: 5 serious events

Other events: 61 other events

Deaths: 0 deaths

Ustekinumab 90 mg (After CP)

Serious events: 4 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo (CP) n=32 participants at risk Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=64 participants at risk Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=62 participants at risk Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Placebo A (After CP) n=15 participants at risk After the controlled period (that is \[i.e.\], during the active drug treatment period \[Weeks 12-64\]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.	Placebo B (After CP) n=13 participants at risk After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.	Ustekinumab 45 mg (After CP) n=64 participants at risk After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.	Ustekinumab 90 mg (After CP) n=62 participants at risk After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Infections and infestations Cellulitis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Pharyngitis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Pneumonia	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Nervous system disorders Cerebral haemorrhage	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Eye disorders Cataract	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Cardiac disorders Cardiac failure congestive	3.1% 1/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Colonic polyp	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Psoriasis	3.1% 1/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Dermatitis exfoliative	3.1% 1/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Electrocardiogram abnormal	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Dislocation of joint prosthesis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.

Other adverse events

Measure	Placebo (CP) n=32 participants at risk Placebo 0.5 ml and 1.0 ml was administered subcutaneously (SC) on Weeks 0 and 4 respectively during the controlled period (Weeks 0-12).	Ustekinumab 45 mg (CP) n=64 participants at risk Ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Ustekinumab 90 mg (CP) n=62 participants at risk Ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC on Weeks 0 and 4 during the controlled period (Weeks 0-12).	Placebo A (After CP) n=15 participants at risk After the controlled period (that is \[i.e.\], during the active drug treatment period \[Weeks 12-64\]), the placebo group was randomized into 2 groups, including Placebo A, in which ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) was administered SC at Weeks 12, 16, 28, 40, and 52. Participants were then followed until Week 72.	Placebo B (After CP) n=13 participants at risk After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), the placebo group was randomized into 2 groups, including Placebo B, in which ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) was administered SC at Weeks 12, 16, 28, 40, and 52.	Ustekinumab 45 mg (After CP) n=64 participants at risk After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 45 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 45 mg (0.5 ml) and placebo (1.0 ml) SC at Weeks 16, 28, 40 and 52.	Ustekinumab 90 mg (After CP) n=62 participants at risk After the controlled period (i.e., during the active drug treatment period \[Weeks 12-64\]), participants in the ustekinumab 90 mg group received placebo (0.5 ml and 1.0 ml) SC at Week 12 followed by ustekinumab 90 mg (1.0 ml) and placebo (0.5 ml) SC at Weeks 16, 28, 40 and 52.
Infections and infestations Upper respiratory tract infection	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Nasopharyngitis	9.4% 3/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	15.6% 10/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	16.1% 10/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	53.3% 8/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	69.2% 9/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	54.7% 35/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	46.8% 29/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Psoriasis	21.9% 7/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood triglycerides increased	3.1% 1/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	10.9% 7/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	13.3% 2/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	15.4% 2/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	20.3% 13/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	12.9% 8/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Eosinophil count increased	3.1% 1/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	4.7% 3/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.5% 4/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.2% 4/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	8.1% 5/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Liver function test abnormal	6.2% 2/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Tinea pedis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	11.3% 7/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Influenza	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.1% 2/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	9.7% 6/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Folliculitis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	13.3% 2/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	4.8% 3/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Pharyngitis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Rhinitis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Hordeolum	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Tinea cruris	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Infected epidermal cyst	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Immune system disorders Seasonal allergy	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	23.1% 3/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	12.5% 8/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	14.5% 9/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.2% 4/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Psychiatric disorders Depression	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Nervous system disorders Headache	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.8% 5/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Ear and labyrinth disorders Tinnitus	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Cardiac disorders Arrhythmia	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Vascular disorders Hypertension	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	4.7% 3/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.5% 4/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	4.7% 3/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.5% 4/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	15.4% 2/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.8% 5/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Nausea	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Periodontal disease	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Tooth disorder	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.1% 2/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Periodontitis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Cheilitis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Constipation	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Stomach discomfort	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Toothache	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Gastrointestinal disorders Vomiting	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.8% 5/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	4.8% 3/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.2% 4/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	8.1% 5/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Dermatitis contact	3.1% 1/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	15.4% 2/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.5% 4/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	15.4% 2/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	4.8% 3/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Xeroderma	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.1% 2/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Dyshidrosis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.8% 5/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.5% 4/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.8% 5/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Renal and urinary disorders Calculus ureteric	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Renal and urinary disorders Calculus urethral	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Renal and urinary disorders Renal atrophy	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Reproductive system and breast disorders Acquired hydrocele	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
General disorders Pyrexia	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.1% 2/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
General disorders Fatigue	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
General disorders Feeling abnormal	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood creatine phosphokinase increased	3.1% 1/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Alanine aminotransferase increased	3.1% 1/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations White blood cell count increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.8% 5/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.5% 4/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.8% 5/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	4.8% 3/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Glucose urine present	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	4.7% 3/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	4.8% 3/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Lymphocyte count decreased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	4.7% 3/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.8% 5/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood bilirubin increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	4.7% 3/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood cholesterol increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.2% 4/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations C-reactive protein increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	4.8% 3/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood amylase increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Red blood cell count increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood phosphorus decreased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood cholesterol decreased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood pressure increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood pressure decreased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Fibrin D dimer increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Haemoglobin increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.2% 4/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	8.1% 5/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	8.1% 5/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Wound	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	15.4% 2/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	6.7% 1/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Injury, poisoning and procedural complications Post procedural swelling	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Tonsillitis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	7.7% 1/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Cellulitis	3.1% 1/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Molluscum contagiosum	3.1% 1/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Sinusitis	3.1% 1/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Oral candidiasis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Otitis externa	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Infections and infestations Paronychia	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Heat rash	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Neurodermatitis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Basophil count increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.1% 2/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood uric acid increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Protein urine present	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	3.2% 2/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood albumin decreased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Investigations Blood urea decreased	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.
Skin and subcutaneous tissue disorders Photodermatosis	0.00% 0/32 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	1.6% 1/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/15 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/13 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/64 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.	0.00% 0/62 • Baseline up to Week 72 Safety population included all randomized participants who received at least one dose of the study drug.

Additional Information

Senior Director, Clinical Development

Janssen Research & Development, LLC

Phone: 793-7633

Results disclosure agreements

• Principal investigator is a sponsor employee The disclosure restriction on Principle investigator is that the sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the sponsor requires.
• Publication restrictions are in place

Restriction type: OTHER