Trial Outcomes & Findings for Comparison of Secukinumab 300 mg Combined With a Lifestyle Intervention to Secukinumab Alone for the Treatment of Moderate to Severe Psoriasis Patients With Concomitant Metabolic Syndrome (NCT NCT03440736)

Last Updated: 2026-04-22

Results Overview

The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 represents patients achieving \>= 90% improvement (reduction) in PASI score compared to Baseline. Patients with missing PASI at Week 28 were counted as non-responders.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

781 participants

Primary outcome timeframe

Baseline, Week 28

Results posted on

2026-04-22

Participant Flow

This study was conducted at 81 centers in Germany.

Patients were screened for eligibility for a period of 1 to 4 weeks prior to inclusion in the study.

Participant milestones

Participant milestones
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.	Extension Period: Lifestyle Intervention All patients from Core Study who either switched OR continued on Lifestyle Intervention (a structured and standardized program to improve patients metabolic status and to lose weight, not considered as study treatment) only during the Extension period.	Extension Period: Lifestyle Intervention + Secukinumab All patients from Core Study who either continued Secukinumab and initiated lifestyle intervention in the Extension period OR continued both Secukinumab and lifestyle intervention during the Extension period.	Extension Period: Secukinumab All patients from Core Study who either switched OR continued on Secukinumab only during the Extension period.
Core Study (Week 0 to Week 28) STARTED	371	410	0	0	0
Core Study (Week 0 to Week 28) Full Analysis Set (FAS)	371	409	0	0	0
Core Study (Week 0 to Week 28) Safety Set (SAF)	371	409	0	0	0
Core Study (Week 0 to Week 28) COMPLETED	342	375	0	0	0
Core Study (Week 0 to Week 28) NOT COMPLETED	29	35	0	0	0
Extension Period (Week 28 to Week 56) STARTED	0	0	189	164	347
Extension Period (Week 28 to Week 56) Continued Lifestyle Intervention in Extension Period	0	0	119	109	0
Extension Period (Week 28 to Week 56) Initiated Lifestyle Intervention in Extension Period	0	0	70	55	0
Extension Period (Week 28 to Week 56) Secukinumab Given as Concomitant Medication During Extension Period	0	0	0	162	157
Extension Period (Week 28 to Week 56) COMPLETED	0	0	182	160	347
Extension Period (Week 28 to Week 56) NOT COMPLETED	0	0	7	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.	Extension Period: Lifestyle Intervention All patients from Core Study who either switched OR continued on Lifestyle Intervention (a structured and standardized program to improve patients metabolic status and to lose weight, not considered as study treatment) only during the Extension period.	Extension Period: Lifestyle Intervention + Secukinumab All patients from Core Study who either continued Secukinumab and initiated lifestyle intervention in the Extension period OR continued both Secukinumab and lifestyle intervention during the Extension period.
Core Study (Week 0 to Week 28) Adverse Event	8	7	0	0
Core Study (Week 0 to Week 28) Lack of Efficacy	2	3	0	0
Core Study (Week 0 to Week 28) Non-compliance with study treatment	1	1	0	0
Core Study (Week 0 to Week 28) Protocol Violation	4	4	0	0
Core Study (Week 0 to Week 28) Lost to Follow-up	2	8	0	0
Core Study (Week 0 to Week 28) Physician Decision	2	2	0	0
Core Study (Week 0 to Week 28) Withdrawal by Subject	9	10	0	0
Core Study (Week 0 to Week 28) Subject discontinued the study due to emergency	1	0	0	0
Extension Period (Week 28 to Week 56) Adverse Event	0	0	1	0
Extension Period (Week 28 to Week 56) Lost to Follow-up	0	0	0	2
Extension Period (Week 28 to Week 56) Subject/guardian decision	0	0	6	2

Baseline Characteristics

Comparison of Secukinumab 300 mg Combined With a Lifestyle Intervention to Secukinumab Alone for the Treatment of Moderate to Severe Psoriasis Patients With Concomitant Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=371 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=409 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.	Total n=780 Participants Total of all reporting groups
Race/Ethnicity, Customized Asian	7 Participants n=60 Participants	1 Participants n=56 Participants	8 Participants n=116 Participants
Race/Ethnicity, Customized Caucasian	359 Participants n=60 Participants	397 Participants n=56 Participants	756 Participants n=116 Participants
Age, Continuous	50.4 Years STANDARD_DEVIATION 13.29 • n=60 Participants	50.1 Years STANDARD_DEVIATION 12.48 • n=56 Participants	50.2 Years STANDARD_DEVIATION 12.86 • n=116 Participants
Sex: Female, Male Female	105 Participants n=60 Participants	115 Participants n=56 Participants	220 Participants n=116 Participants
Sex: Female, Male Male	266 Participants n=60 Participants	294 Participants n=56 Participants	560 Participants n=116 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=60 Participants	2 Participants n=56 Participants	4 Participants n=116 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=60 Participants	1 Participants n=56 Participants	1 Participants n=116 Participants
Race/Ethnicity, Customized Other	3 Participants n=60 Participants	8 Participants n=56 Participants	11 Participants n=116 Participants

PRIMARY outcome

Timeframe: Baseline, Week 28

Population: Full Analysis Set (FAS)

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=371 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=409 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 at Week 28	219 Participants	261 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS)

The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 represents patients achieving \>= 75% improvement (reduction) in PASI score compared to Baseline.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=371 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=409 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 75 Over Time Week 1	2 Participants	1 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 75 Over Time Week 2	11 Participants	3 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 75 Over Time Week 3	50 Participants	56 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 75 Over Time Week 4	108 Participants	135 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 75 Over Time Week 8	239 Participants	265 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 75 Over Time Week 12	241 Participants	276 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 75 Over Time Week 16	287 Participants	332 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 75 Over Time Week 20	290 Participants	333 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 75 Over Time Week 24	285 Participants	333 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 75 Over Time Week 28	286 Participants	335 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Population: Full Analysis Set (FAS)

The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 represents patients achieving ≥ 90% improvement (reduction) in PASI score compared to Baseline.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=371 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=409 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 Over Time Week 1	0 Participants	0 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 Over Time Week 2	2 Participants	0 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 Over Time Week 3	7 Participants	4 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 Over Time Week 4	25 Participants	30 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 Over Time Week 8	130 Participants	141 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 Over Time Week 12	159 Participants	182 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 Over Time Week 16	215 Participants	241 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 Over Time Week 20	217 Participants	242 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 90 Over Time Week 24	224 Participants	251 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS)

The Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, trunk, upper limbs, lower limbs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 100 response/remission represents patients achieving complete clearing of psoriasis (PASI = 0) compared to Baseline.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=371 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=409 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 100 Over Time Week 1	0 Participants	0 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 100 Over Time Week 2	1 Participants	0 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 100 Over Time Week 3	1 Participants	0 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 100 Over Time Week 4	5 Participants	4 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 100 Over Time Week 8	35 Participants	39 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 100 Over Time Week 12	48 Participants	71 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 100 Over Time Week 16	82 Participants	115 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 100 Over Time Week 20	100 Participants	108 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 100 Over Time Week 24	101 Participants	115 Participants
Percentage of Patients Achieving Psoriasis Area and Severity Index (PASI) Score of 100 Over Time Week 28	105 Participants	118 Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

The Psoriasis Area and Severity Index (PASI) combines lesion severity and the extent of affected area into a single score ranging from 0 (no disease) to 72 (maximum disease). The body is divided into four regions for scoring: head, trunk, upper limbs, and lower limbs. Each region is scored individually, and these scores are then combined to calculate the final PASI. For each region, the percentage of skin involved is estimated on a scale from 0 (0%) to 6 (90-100%), and severity is assessed based on clinical signs such as erythema, induration, and desquamation, on a scale from 0 (none) to 4 (maximum). The final PASI is the sum of the severity parameters for each area multiplied by the area score weight of the section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). A negative change in the absolute PASI score indicates a reduction in psoriasis severity, signifying an improvement in the patient's condition.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=365 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=402 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Difference From Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score Over Time Week 1	-2.8 Unit on a scale Standard Error 0.22	-2.9 Unit on a scale Standard Error 0.21
Mean Difference From Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score Over Time Week 2	-6.6 Unit on a scale Standard Error 0.23	-6.9 Unit on a scale Standard Error 0.22
Mean Difference From Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score Over Time Week 3	-9.9 Unit on a scale Standard Error 0.25	-10.1 Unit on a scale Standard Error 0.23
Mean Difference From Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score Over Time Week 4	-12.0 Unit on a scale Standard Error 0.26	-12.4 Unit on a scale Standard Error 0.25
Mean Difference From Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score Over Time Week 8	-15.5 Unit on a scale Standard Error 0.26	-15.5 Unit on a scale Standard Error 0.25
Mean Difference From Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score Over Time Week 12	-16.6 Unit on a scale Standard Error 0.26	-16.9 Unit on a scale Standard Error 0.25
Mean Difference From Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score Over Time Week 16	-17.2 Unit on a scale Standard Error 0.27	-17.3 Unit on a scale Standard Error 0.26
Mean Difference From Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score Over Time Week 20	-17.4 Unit on a scale Standard Error 0.27	-17.5 Unit on a scale Standard Error 0.26
Mean Difference From Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score Over Time Week 24	-17.4 Unit on a scale Standard Error 0.28	-17.6 Unit on a scale Standard Error 0.26
Mean Difference From Baseline in Absolute Psoriasis Area and Severity Index (PASI) Score Over Time Week 28	-17.3 Unit on a scale Standard Error 0.29	-17.6 Unit on a scale Standard Error 0.27

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

High-sensitivity C-reactive Protein (hsCRP) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=362 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=392 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Change from BL @ Week 28	-0.101 milligram/litre (mg/L) Standard Deviation 0.7694	-0.141 milligram/litre (mg/L) Standard Deviation 0.4254
Mean Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Change from BL @ Week 24	-0.087 milligram/litre (mg/L) Standard Deviation 0.7964	-0.097 milligram/litre (mg/L) Standard Deviation 0.5783
Mean Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Change from BL @ Week 20	-0.074 milligram/litre (mg/L) Standard Deviation 0.7019	-0.113 milligram/litre (mg/L) Standard Deviation 0.5109
Mean Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Change from BL @ Week 2	-0.087 milligram/litre (mg/L) Standard Deviation 0.7242	-0.124 milligram/litre (mg/L) Standard Deviation 0.5178
Mean Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Change from BL @ Week 4	-0.098 milligram/litre (mg/L) Standard Deviation 0.6860	-0.117 milligram/litre (mg/L) Standard Deviation 0.5218
Mean Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Change from BL @ Week 8	-0.117 milligram/litre (mg/L) Standard Deviation 0.6797	-0.092 milligram/litre (mg/L) Standard Deviation 0.5733
Mean Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Change from BL @ Week 12	-0.069 milligram/litre (mg/L) Standard Deviation 0.7539	-0.078 milligram/litre (mg/L) Standard Deviation 0.7599
Mean Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Change from BL @ Week 16	-0.100 milligram/litre (mg/L) Standard Deviation 0.6654	-0.116 milligram/litre (mg/L) Standard Deviation 0.4679

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Hemoglobin A1c (HbA1c) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=355 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=392 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in Hemoglobin A1c (HbA1c) Change from BL @ Week 8	0.01 Percentage (%) of HbA1c Standard Deviation 0.293	-0.07 Percentage (%) of HbA1c Standard Deviation 0.314
Mean Change From Baseline in Hemoglobin A1c (HbA1c) Change from BL @ Week 16	0.03 Percentage (%) of HbA1c Standard Deviation 0.389	-0.06 Percentage (%) of HbA1c Standard Deviation 0.342
Mean Change From Baseline in Hemoglobin A1c (HbA1c) Change from BL @ Week 24	0.03 Percentage (%) of HbA1c Standard Deviation 0.388	-0.04 Percentage (%) of HbA1c Standard Deviation 0.332
Mean Change From Baseline in Hemoglobin A1c (HbA1c) Change from BL @ Week 28	0.03 Percentage (%) of HbA1c Standard Deviation 0.417	-0.05 Percentage (%) of HbA1c Standard Deviation 0.353

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Fructosamine was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=357 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=391 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in Fructosamine Change from BL @ Week 4	-1.0 micromole/liter (µmol/L) Standard Deviation 43.96	-9.6 micromole/liter (µmol/L) Standard Deviation 43.23
Mean Change From Baseline in Fructosamine Change from BL @ Week 8	-2.4 micromole/liter (µmol/L) Standard Deviation 41.24	-4.2 micromole/liter (µmol/L) Standard Deviation 48.95
Mean Change From Baseline in Fructosamine Change from BL @ Week 12	6.6 micromole/liter (µmol/L) Standard Deviation 45.84	-6.4 micromole/liter (µmol/L) Standard Deviation 39.15
Mean Change From Baseline in Fructosamine Change from BL @ Week 16	0.8 micromole/liter (µmol/L) Standard Deviation 45.17	-0.4 micromole/liter (µmol/L) Standard Deviation 48.15
Mean Change From Baseline in Fructosamine Change from BL @ Week 20	-0.6 micromole/liter (µmol/L) Standard Deviation 46.43	-6.4 micromole/liter (µmol/L) Standard Deviation 56.76
Mean Change From Baseline in Fructosamine Change from BL @ Week 24	0.6 micromole/liter (µmol/L) Standard Deviation 44.51	3.9 micromole/liter (µmol/L) Standard Deviation 51.88
Mean Change From Baseline in Fructosamine Change from BL @ Week 28	2.3 micromole/liter (µmol/L) Standard Deviation 47.29	1.7 micromole/liter (µmol/L) Standard Deviation 48.00

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Fasting Plasma Glucose (FPG) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=366 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=402 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in Fasting Plasma Glucose (FPG) Change from BL @ Week 8	0.8 milligram per deciliter (mg/dL) Standard Deviation 17.14	-1.7 milligram per deciliter (mg/dL) Standard Deviation 16.71
Mean Change From Baseline in Fasting Plasma Glucose (FPG) Change from BL @ Week 16	1.9 milligram per deciliter (mg/dL) Standard Deviation 20.51	-2.1 milligram per deciliter (mg/dL) Standard Deviation 16.26
Mean Change From Baseline in Fasting Plasma Glucose (FPG) Change from BL @ Week 28	2.9 milligram per deciliter (mg/dL) Standard Deviation 22.29	-0.5 milligram per deciliter (mg/dL) Standard Deviation 18.60

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Total cholesterol was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=355 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=394 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in Total Cholesterol Change from BL @ Week 8	1.9 milligram per deciliter (mg/dL) Standard Deviation 26.75	-2.5 milligram per deciliter (mg/dL) Standard Deviation 24.84
Mean Change From Baseline in Total Cholesterol Change from BL @ Week 16	-0.2 milligram per deciliter (mg/dL) Standard Deviation 25.33	-1.3 milligram per deciliter (mg/dL) Standard Deviation 25.30
Mean Change From Baseline in Total Cholesterol Change from BL @ Week 28	-0.4 milligram per deciliter (mg/dL) Standard Deviation 30.13	-3.1 milligram per deciliter (mg/dL) Standard Deviation 25.45

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Low-Density Lipoprotein (LDL) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=355 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=394 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in Low-Density Lipoprotein (LDL) Change from BL @ Week 8	1.6 milligram per deciliter (mg/dL) Standard Deviation 21.53	-2.2 milligram per deciliter (mg/dL) Standard Deviation 22.00
Mean Change From Baseline in Low-Density Lipoprotein (LDL) Change from BL @ Week 16	-1.4 milligram per deciliter (mg/dL) Standard Deviation 22.67	-0.9 milligram per deciliter (mg/dL) Standard Deviation 24.14
Mean Change From Baseline in Low-Density Lipoprotein (LDL) Change from BL @ Week 28	1.9 milligram per deciliter (mg/dL) Standard Deviation 25.57	-1.2 milligram per deciliter (mg/dL) Standard Deviation 25.10

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

High-Density Lipoprotein (HDL) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=355 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=394 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in High-Density Lipoprotein (HDL) Change from BL @ Week 8	-0.5 milligram per deciliter (mg/dL) Standard Deviation 5.29	-1.0 milligram per deciliter (mg/dL) Standard Deviation 6.20
Mean Change From Baseline in High-Density Lipoprotein (HDL) Change from BL @ Week 16	-0.8 milligram per deciliter (mg/dL) Standard Deviation 5.92	0.0 milligram per deciliter (mg/dL) Standard Deviation 6.69
Mean Change From Baseline in High-Density Lipoprotein (HDL) Change from BL @ Week 28	0.0 milligram per deciliter (mg/dL) Standard Deviation 6.91	0.5 milligram per deciliter (mg/dL) Standard Deviation 7.29

SECONDARY outcome

Timeframe: Baseline, Week 8, Week 16, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Triglycerides were evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=355 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=394 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in Triglycerides Change from BL @ Week 8	2.5 milligram per deciliter (mg/dL) Standard Deviation 100.55	-2.7 milligram per deciliter (mg/dL) Standard Deviation 100.29
Mean Change From Baseline in Triglycerides Change from BL @ Week 16	11.0 milligram per deciliter (mg/dL) Standard Deviation 146.64	-1.7 milligram per deciliter (mg/dL) Standard Deviation 111.36
Mean Change From Baseline in Triglycerides Change from BL @ Week 28	-5.9 milligram per deciliter (mg/dL) Standard Deviation 187.93	-6.3 milligram per deciliter (mg/dL) Standard Deviation 98.69

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Waist circumference was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=365 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=402 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in Waist Circumference Change from BL @ Week 1	-0.5 Centimeter (cm) Standard Deviation 2.97	-0.3 Centimeter (cm) Standard Deviation 3.41
Mean Change From Baseline in Waist Circumference Change from BL @ Week 2	-0.7 Centimeter (cm) Standard Deviation 3.74	-1.1 Centimeter (cm) Standard Deviation 4.30
Mean Change From Baseline in Waist Circumference Change from BL @ Week 3	-0.8 Centimeter (cm) Standard Deviation 3.66	-1.3 Centimeter (cm) Standard Deviation 4.71
Mean Change From Baseline in Waist Circumference Change from BL @ Week 4	-0.9 Centimeter (cm) Standard Deviation 3.92	-2.0 Centimeter (cm) Standard Deviation 4.54
Mean Change From Baseline in Waist Circumference Change from BL @ Week 8	-1.2 Centimeter (cm) Standard Deviation 4.53	-2.6 Centimeter (cm) Standard Deviation 5.34
Mean Change From Baseline in Waist Circumference Change from BL @ Week 12	-1.1 Centimeter (cm) Standard Deviation 4.43	-2.9 Centimeter (cm) Standard Deviation 5.68
Mean Change From Baseline in Waist Circumference Change from BL @ Week 16	-1.4 Centimeter (cm) Standard Deviation 5.22	-3.5 Centimeter (cm) Standard Deviation 6.09
Mean Change From Baseline in Waist Circumference Change from BL @ Week 20	-1.3 Centimeter (cm) Standard Deviation 5.47	-3.4 Centimeter (cm) Standard Deviation 7.00
Mean Change From Baseline in Waist Circumference Change from BL @ Week 24	-1.4 Centimeter (cm) Standard Deviation 5.34	-3.7 Centimeter (cm) Standard Deviation 6.72
Mean Change From Baseline in Waist Circumference Change from BL @ Week 28	-1.5 Centimeter (cm) Standard Deviation 5.50	-3.9 Centimeter (cm) Standard Deviation 7.04

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Body weight was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=365 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=402 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in Body Weight Change from BL @ Week 1	0.06 Kilogram (kg) Standard Deviation 2.120	-0.33 Kilogram (kg) Standard Deviation 1.401
Mean Change From Baseline in Body Weight Change from BL @ Week 2	-0.04 Kilogram (kg) Standard Deviation 1.729	-0.75 Kilogram (kg) Standard Deviation 1.739
Mean Change From Baseline in Body Weight Change from BL @ Week 3	-0.05 Kilogram (kg) Standard Deviation 2.189	-1.08 Kilogram (kg) Standard Deviation 2.278
Mean Change From Baseline in Body Weight Change from BL @ Week 4	-0.08 Kilogram (kg) Standard Deviation 2.326	-1.20 Kilogram (kg) Standard Deviation 2.177
Mean Change From Baseline in Body Weight Change from BL @ Week 8	-0.15 Kilogram (kg) Standard Deviation 2.447	-1.84 Kilogram (kg) Standard Deviation 3.471
Mean Change From Baseline in Body Weight Change from BL @ Week 12	0.02 Kilogram (kg) Standard Deviation 2.726	-2.38 Kilogram (kg) Standard Deviation 4.150
Mean Change From Baseline in Body Weight Change from BL @ Week 16	-0.21 Kilogram (kg) Standard Deviation 3.243	-2.65 Kilogram (kg) Standard Deviation 4.891
Mean Change From Baseline in Body Weight Change from BL @ Week 20	-0.36 Kilogram (kg) Standard Deviation 3.581	-2.72 Kilogram (kg) Standard Deviation 5.480
Mean Change From Baseline in Body Weight Change from BL @ Week 24	-0.30 Kilogram (kg) Standard Deviation 3.815	-2.86 Kilogram (kg) Standard Deviation 6.056
Mean Change From Baseline in Body Weight Change from BL @ Week 28	-0.17 Kilogram (kg) Standard Deviation 3.803	-3.03 Kilogram (kg) Standard Deviation 6.107

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Body Mass Index (BMI) was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=365 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=402 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in Body Mass Index (BMI) Change from BL @ Week 1	0.015 Kilogram by square meter (kg/m^2) Standard Deviation 0.6846	-0.110 Kilogram by square meter (kg/m^2) Standard Deviation 0.4515
Mean Change From Baseline in Body Mass Index (BMI) Change from BL @ Week 2	-0.015 Kilogram by square meter (kg/m^2) Standard Deviation 0.5545	-0.240 Kilogram by square meter (kg/m^2) Standard Deviation 0.5649
Mean Change From Baseline in Body Mass Index (BMI) Change from BL @ Week 3	-0.014 Kilogram by square meter (kg/m^2) Standard Deviation 0.7076	-0.346 Kilogram by square meter (kg/m^2) Standard Deviation 0.7352
Mean Change From Baseline in Body Mass Index (BMI) Change from BL @ Week 4	-0.027 Kilogram by square meter (kg/m^2) Standard Deviation 0.7451	-0.386 Kilogram by square meter (kg/m^2) Standard Deviation 0.7128
Mean Change From Baseline in Body Mass Index (BMI) Change from BL @ Week 8	-0.047 Kilogram by square meter (kg/m^2) Standard Deviation 0.7838	-0.582 Kilogram by square meter (kg/m^2) Standard Deviation 1.1641
Mean Change From Baseline in Body Mass Index (BMI) Change from BL @ Week 12	0.009 Kilogram by square meter (kg/m^2) Standard Deviation 0.8768	-0.758 Kilogram by square meter (kg/m^2) Standard Deviation 1.3522
Mean Change From Baseline in Body Mass Index (BMI) Change from BL @ Week 16	-0.070 Kilogram by square meter (kg/m^2) Standard Deviation 1.0432	-0.843 Kilogram by square meter (kg/m^2) Standard Deviation 1.5780
Mean Change From Baseline in Body Mass Index (BMI) Change from BL @ Week 20	-0.113 Kilogram by square meter (kg/m^2) Standard Deviation 1.1627	-0.864 Kilogram by square meter (kg/m^2) Standard Deviation 1.7769
Mean Change From Baseline in Body Mass Index (BMI) Change from BL @ Week 24	-0.094 Kilogram by square meter (kg/m^2) Standard Deviation 1.2417	-0.906 Kilogram by square meter (kg/m^2) Standard Deviation 1.9591
Mean Change From Baseline in Body Mass Index (BMI) Change from BL @ Week 28	-0.054 Kilogram by square meter (kg/m^2) Standard Deviation 1.2309	-0.961 Kilogram by square meter (kg/m^2) Standard Deviation 1.9665

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Systolic Blood Pressure was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=365 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=402 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in Systolic Blood Pressure (SBP) Change from BL @ Week 1	-0.66 millimeter of mercury (mmHg) Standard Deviation 10.033	-1.44 millimeter of mercury (mmHg) Standard Deviation 10.964
Mean Change From Baseline in Systolic Blood Pressure (SBP) Change from BL @ Week 2	-1.24 millimeter of mercury (mmHg) Standard Deviation 11.499	-3.12 millimeter of mercury (mmHg) Standard Deviation 11.422
Mean Change From Baseline in Systolic Blood Pressure (SBP) Change from BL @ Week 3	-1.05 millimeter of mercury (mmHg) Standard Deviation 11.086	-3.67 millimeter of mercury (mmHg) Standard Deviation 12.740
Mean Change From Baseline in Systolic Blood Pressure (SBP) Change from BL @ Week 4	-3.02 millimeter of mercury (mmHg) Standard Deviation 10.693	-4.33 millimeter of mercury (mmHg) Standard Deviation 11.763
Mean Change From Baseline in Systolic Blood Pressure (SBP) Change from BL @ Week 8	-2.52 millimeter of mercury (mmHg) Standard Deviation 12.394	-3.88 millimeter of mercury (mmHg) Standard Deviation 12.545
Mean Change From Baseline in Systolic Blood Pressure (SBP) Change from BL @ Week 12	-1.64 millimeter of mercury (mmHg) Standard Deviation 12.054	-3.65 millimeter of mercury (mmHg) Standard Deviation 12.982
Mean Change From Baseline in Systolic Blood Pressure (SBP) Change from BL @ Week 16	-3.03 millimeter of mercury (mmHg) Standard Deviation 12.646	-4.33 millimeter of mercury (mmHg) Standard Deviation 12.980
Mean Change From Baseline in Systolic Blood Pressure (SBP) Change from BL @ Week 20	-1.65 millimeter of mercury (mmHg) Standard Deviation 12.067	-3.70 millimeter of mercury (mmHg) Standard Deviation 13.323
Mean Change From Baseline in Systolic Blood Pressure (SBP) Change from BL @ Week 24	-2.53 millimeter of mercury (mmHg) Standard Deviation 12.681	-4.35 millimeter of mercury (mmHg) Standard Deviation 13.455
Mean Change From Baseline in Systolic Blood Pressure (SBP) Change from BL @ Week 28	-2.56 millimeter of mercury (mmHg) Standard Deviation 12.179	-4.28 millimeter of mercury (mmHg) Standard Deviation 13.475

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Diastolic Blood Pressure was evaluated in both treatment arms throughout the duration of the core study and summarized using descriptive statistics.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=365 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=402 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in Diastolic Blood Pressure (DBP) Change from BL @ Week 8	-0.60 millimeter of mercury (mmHg) Standard Deviation 7.510	-1.51 millimeter of mercury (mmHg) Standard Deviation 7.517
Mean Change From Baseline in Diastolic Blood Pressure (DBP) Change from BL @ Week 1	-0.39 millimeter of mercury (mmHg) Standard Deviation 6.761	-1.02 millimeter of mercury (mmHg) Standard Deviation 7.495
Mean Change From Baseline in Diastolic Blood Pressure (DBP) Change from BL @ Week 2	-0.65 millimeter of mercury (mmHg) Standard Deviation 7.460	-1.16 millimeter of mercury (mmHg) Standard Deviation 7.630
Mean Change From Baseline in Diastolic Blood Pressure (DBP) Change from BL @ Week 3	-0.62 millimeter of mercury (mmHg) Standard Deviation 7.180	-1.66 millimeter of mercury (mmHg) Standard Deviation 8.030
Mean Change From Baseline in Diastolic Blood Pressure (DBP) Change from BL @ Week 4	-1.29 millimeter of mercury (mmHg) Standard Deviation 7.349	-2.00 millimeter of mercury (mmHg) Standard Deviation 7.925
Mean Change From Baseline in Diastolic Blood Pressure (DBP) Change from BL @ Week 12	-0.37 millimeter of mercury (mmHg) Standard Deviation 7.820	-1.56 millimeter of mercury (mmHg) Standard Deviation 8.754
Mean Change From Baseline in Diastolic Blood Pressure (DBP) Change from BL @ Week 16	-0.60 millimeter of mercury (mmHg) Standard Deviation 7.969	-1.99 millimeter of mercury (mmHg) Standard Deviation 8.211
Mean Change From Baseline in Diastolic Blood Pressure (DBP) Change from BL @ Week 20	-0.59 millimeter of mercury (mmHg) Standard Deviation 8.040	-2.28 millimeter of mercury (mmHg) Standard Deviation 8.275
Mean Change From Baseline in Diastolic Blood Pressure (DBP) Change from BL @ Week 24	-0.73 millimeter of mercury (mmHg) Standard Deviation 8.270	-2.04 millimeter of mercury (mmHg) Standard Deviation 8.701
Mean Change From Baseline in Diastolic Blood Pressure (DBP) Change from BL @ Week 28	-0.48 millimeter of mercury (mmHg) Standard Deviation 8.417	-1.65 millimeter of mercury (mmHg) Standard Deviation 8.877

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS).

The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question refers to the impact of the skin disease on the patient's life (symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment) over the previous week and is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=371 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=409 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Dermatology Life Quality Index (DLQI) Total Score Over Time Baseline	19.55 Unit on a scale Standard Deviation 5.124	19.12 Unit on a scale Standard Deviation 5.449
Dermatology Life Quality Index (DLQI) Total Score Over Time Week 4	8.57 Unit on a scale Standard Deviation 5.932	7.92 Unit on a scale Standard Deviation 6.119
Dermatology Life Quality Index (DLQI) Total Score Over Time Week 8	5.47 Unit on a scale Standard Deviation 5.725	5.18 Unit on a scale Standard Deviation 5.405
Dermatology Life Quality Index (DLQI) Total Score Over Time Week 12	4.29 Unit on a scale Standard Deviation 5.341	4.16 Unit on a scale Standard Deviation 5.100
Dermatology Life Quality Index (DLQI) Total Score Over Time Week 16	3.90 Unit on a scale Standard Deviation 5.374	3.73 Unit on a scale Standard Deviation 4.927
Dermatology Life Quality Index (DLQI) Total Score Over Time Week 20	3.43 Unit on a scale Standard Deviation 5.101	3.43 Unit on a scale Standard Deviation 5.061
Dermatology Life Quality Index (DLQI) Total Score Over Time Week 24	3.42 Unit on a scale Standard Deviation 5.261	3.33 Unit on a scale Standard Deviation 4.824
Dermatology Life Quality Index (DLQI) Total Score Over Time Week 28	3.42 Unit on a scale Standard Deviation 5.242	3.30 Unit on a scale Standard Deviation 5.312

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=371 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=409 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time Change from BL @ Week 4	-11.0 Unit on a scale Standard Deviation 6.66	-11.3 Unit on a scale Standard Deviation 6.68
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time Change from BL @ Week 8	-14.1 Unit on a scale Standard Deviation 6.91	-14.1 Unit on a scale Standard Deviation 6.60
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time Change from BL @ Week 12	-15.5 Unit on a scale Standard Deviation 6.68	-15.1 Unit on a scale Standard Deviation 6.51
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time Change from BL @ Week 16	-15.7 Unit on a scale Standard Deviation 6.60	-15.4 Unit on a scale Standard Deviation 6.33
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time Change from BL @ Week 20	-16.2 Unit on a scale Standard Deviation 6.81	-15.7 Unit on a scale Standard Deviation 6.66
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time Change from BL @ Week 24	-16.1 Unit on a scale Standard Deviation 6.75	-15.8 Unit on a scale Standard Deviation 6.46
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time Change from BL @ Week 28	-16.1 Unit on a scale Standard Deviation 6.80	-15.9 Unit on a scale Standard Deviation 6.67

SECONDARY outcome

Timeframe: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

All patients with DLQI score 0 and 1 were considered as responders and patients with DLQI score \>=2 were considered as non-responders. Subjects with missing DLQI score were counted as non-responders.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=366 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=395 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 24 · Non-Responders	148 Participants	175 Participants
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 8 · Non-Responders	249 Participants	269 Participants
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 8 · Responders	111 Participants	126 Participants
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 12 · Non-Responders	179 Participants	192 Participants
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 12 · Responders	130 Participants	143 Participants
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 16 · Non-Responders	176 Participants	201 Participants
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 16 · Responders	178 Participants	187 Participants
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 20 · Non-Responders	153 Participants	170 Participants
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 20 · Responders	193 Participants	210 Participants
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 24 · Responders	189 Participants	203 Participants
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 28 · Non-Responders	145 Participants	154 Participants
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 28 · Responders	189 Participants	212 Participants
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 4 · Non-Responders	323 Participants	344 Participants
Percentage of Patients With Dermatology Life Quality Index (DLQI) Response Week 4 · Responders	43 Participants	50 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS)

The 5-item World Health Organization Well-Being Index (WHO-5) is a validated, short questionnaire consisting of 5 simple questions, assessing subjective psychological well-being of the respondents. The recall period is the previous two weeks. Each item has 6 response categories, ranging from 5 ("the whole time") to 0 ("at no time point"). The WHO-5 total score is the sum of the 5 questions and ranges from 0 to 25, with 0 representing worst possible and 25 representing best possible quality of life.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=371 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=409 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
World Health Organization Well-Being Index (WHO-5) Total Score Over Time Baseline	10.46 Unit on a scale Standard Deviation 5.208	10.62 Unit on a scale Standard Deviation 5.283
World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 4	14.45 Unit on a scale Standard Deviation 5.236	15.52 Unit on a scale Standard Deviation 4.921
World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 8	15.65 Unit on a scale Standard Deviation 4.889	15.99 Unit on a scale Standard Deviation 4.697
World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 12	15.77 Unit on a scale Standard Deviation 5.083	16.37 Unit on a scale Standard Deviation 4.824
World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 16	15.91 Unit on a scale Standard Deviation 5.334	16.45 Unit on a scale Standard Deviation 4.902
World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 20	16.30 Unit on a scale Standard Deviation 5.364	16.44 Unit on a scale Standard Deviation 4.978
World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 24	16.47 Unit on a scale Standard Deviation 5.173	16.55 Unit on a scale Standard Deviation 4.865
World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 28	16.20 Unit on a scale Standard Deviation 5.583	16.69 Unit on a scale Standard Deviation 4.910

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=365 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=395 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Mean Change From Baseline in World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 20	5.8 Unit on a scale Standard Deviation 6.08	5.8 Unit on a scale Standard Deviation 5.79
Mean Change From Baseline in World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 4	4.0 Unit on a scale Standard Deviation 5.21	4.9 Unit on a scale Standard Deviation 5.51
Mean Change From Baseline in World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 8	5.1 Unit on a scale Standard Deviation 5.61	5.4 Unit on a scale Standard Deviation 5.76
Mean Change From Baseline in World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 12	5.2 Unit on a scale Standard Deviation 5.73	5.7 Unit on a scale Standard Deviation 5.95
Mean Change From Baseline in World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 16	5.4 Unit on a scale Standard Deviation 5.59	5.8 Unit on a scale Standard Deviation 5.85
Mean Change From Baseline in World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 24	5.9 Unit on a scale Standard Deviation 5.65	5.9 Unit on a scale Standard Deviation 6.19
Mean Change From Baseline in World Health Organization Well-Being Index (WHO-5) Total Score Over Time Week 28	5.6 Unit on a scale Standard Deviation 6.20	5.9 Unit on a scale Standard Deviation 6.12

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

A self-administered, 11-point numeric rating scale (NRS, 0-10) was used to evaluate the subject's assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment of: * Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours * Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours * Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours Subjects had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represented the absence or null end of the pain, itching, or scale intensity (i.e., no pain, itching or scaling) and the 10 represented the other extreme of pain, itching, or scaling intensity (i.e., pain, itching or scaling as bad as it could be). The number that the patient selected represented his or her intensity score.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=371 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=409 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Participant's Self-assessed Pain, Itching and Scaling Over Time Pain at Baseline	4.9 Unit on a scale Standard Deviation 2.93	4.6 Unit on a scale Standard Deviation 2.87
Participant's Self-assessed Pain, Itching and Scaling Over Time Pain at week 4	1.9 Unit on a scale Standard Deviation 2.29	1.7 Unit on a scale Standard Deviation 2.23
Participant's Self-assessed Pain, Itching and Scaling Over Time Pain at week 8	1.1 Unit on a scale Standard Deviation 1.88	1.3 Unit on a scale Standard Deviation 2.05
Participant's Self-assessed Pain, Itching and Scaling Over Time Pain at week 12	1.2 Unit on a scale Standard Deviation 2.14	1.0 Unit on a scale Standard Deviation 1.84
Participant's Self-assessed Pain, Itching and Scaling Over Time Pain at week 16	1.1 Unit on a scale Standard Deviation 2.04	1.1 Unit on a scale Standard Deviation 1.88
Participant's Self-assessed Pain, Itching and Scaling Over Time Pain at week 20	1.0 Unit on a scale Standard Deviation 1.93	1.0 Unit on a scale Standard Deviation 1.81
Participant's Self-assessed Pain, Itching and Scaling Over Time Pain at week 24	1.0 Unit on a scale Standard Deviation 1.91	1.0 Unit on a scale Standard Deviation 1.85
Participant's Self-assessed Pain, Itching and Scaling Over Time Pain at week 28	1.2 Unit on a scale Standard Deviation 2.10	1.0 Unit on a scale Standard Deviation 2.00
Participant's Self-assessed Pain, Itching and Scaling Over Time Itching at Baseline	7.4 Unit on a scale Standard Deviation 2.08	7.1 Unit on a scale Standard Deviation 2.39
Participant's Self-assessed Pain, Itching and Scaling Over Time Itching at week 4	3.2 Unit on a scale Standard Deviation 2.43	3.0 Unit on a scale Standard Deviation 2.60
Participant's Self-assessed Pain, Itching and Scaling Over Time Itching at week 8	2.4 Unit on a scale Standard Deviation 2.36	2.3 Unit on a scale Standard Deviation 2.47
Participant's Self-assessed Pain, Itching and Scaling Over Time Itching at week 12	2.2 Unit on a scale Standard Deviation 2.38	2.0 Unit on a scale Standard Deviation 2.29
Participant's Self-assessed Pain, Itching and Scaling Over Time Itching at week 16	2.0 Unit on a scale Standard Deviation 2.29	2.0 Unit on a scale Standard Deviation 2.43
Participant's Self-assessed Pain, Itching and Scaling Over Time Itching at week 20	1.9 Unit on a scale Standard Deviation 2.23	1.9 Unit on a scale Standard Deviation 2.19
Participant's Self-assessed Pain, Itching and Scaling Over Time Itching at week 24	1.9 Unit on a scale Standard Deviation 2.35	1.8 Unit on a scale Standard Deviation 2.23
Participant's Self-assessed Pain, Itching and Scaling Over Time Itching at week 28	2.0 Unit on a scale Standard Deviation 2.47	1.9 Unit on a scale Standard Deviation 2.38
Participant's Self-assessed Pain, Itching and Scaling Over Time Scaling at Baseline	7.5 Unit on a scale Standard Deviation 2.01	7.3 Unit on a scale Standard Deviation 2.17
Participant's Self-assessed Pain, Itching and Scaling Over Time Scaling at week 4	2.7 Unit on a scale Standard Deviation 2.18	2.4 Unit on a scale Standard Deviation 2.16
Participant's Self-assessed Pain, Itching and Scaling Over Time Scaling at week 8	1.7 Unit on a scale Standard Deviation 1.94	1.7 Unit on a scale Standard Deviation 2.03
Participant's Self-assessed Pain, Itching and Scaling Over Time Scaling at week 12	1.7 Unit on a scale Standard Deviation 2.00	1.6 Unit on a scale Standard Deviation 1.90
Participant's Self-assessed Pain, Itching and Scaling Over Time Scaling at week 16	1.6 Unit on a scale Standard Deviation 2.10	1.5 Unit on a scale Standard Deviation 1.95
Participant's Self-assessed Pain, Itching and Scaling Over Time Scaling at week 20	1.6 Unit on a scale Standard Deviation 2.10	1.5 Unit on a scale Standard Deviation 1.98
Participant's Self-assessed Pain, Itching and Scaling Over Time Scaling at week 24	1.7 Unit on a scale Standard Deviation 2.22	1.4 Unit on a scale Standard Deviation 1.84
Participant's Self-assessed Pain, Itching and Scaling Over Time Scaling at week 28	1.8 Unit on a scale Standard Deviation 2.28	1.5 Unit on a scale Standard Deviation 2.04

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28

Population: Full Analysis Set (FAS). Only participants with a value at both Baseline and post-baseline visit included.

Outcome measures

Outcome measures
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=371 Participants Patients in arm A received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=409 Participants Patients in arm B received therapy with Secukinumab 300 mg s.c., which consisted of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection was performed at week 24). In addition they participated in a lifestyle intervention program.
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Pain at week 4	-61.4 Percentage change Standard Deviation 44.13	-60.2 Percentage change Standard Deviation 59.10
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Pain at week 8	-74.4 Percentage change Standard Deviation 44.39	-68.5 Percentage change Standard Deviation 53.86
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Pain at week 12	-72.2 Percentage change Standard Deviation 54.73	-76.6 Percentage change Standard Deviation 40.64
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Pain at week 16	-77.3 Percentage change Standard Deviation 38.93	-74.0 Percentage change Standard Deviation 46.10
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Pain at week 20	-78.4 Percentage change Standard Deviation 41.88	-75.2 Percentage change Standard Deviation 43.55
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Pain at week 24	-78.4 Percentage change Standard Deviation 41.88	-75.7 Percentage change Standard Deviation 47.05
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Pain at week 28	-76.3 Percentage change Standard Deviation 42.22	-75.3 Percentage change Standard Deviation 52.42
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Itching at week 4	-54.1 Percentage change Standard Deviation 33.82	-55.8 Percentage change Standard Deviation 41.19
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Itching at week 8	-63.7 Percentage change Standard Deviation 39.78	-66.7 Percentage change Standard Deviation 34.31
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Itching at week 12	-66.6 Percentage change Standard Deviation 40.58	-70.0 Percentage change Standard Deviation 33.53
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Itching at week 16	-70.6 Percentage change Standard Deviation 34.79	-70.0 Percentage change Standard Deviation 35.79
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Itching at week 20	-71.1 Percentage change Standard Deviation 37.64	-73.0 Percentage change Standard Deviation 35.36
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Itching at week 24	-69.6 Percentage change Standard Deviation 46.85	-72.6 Percentage change Standard Deviation 35.64
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Itching at week 28	-68.5 Percentage change Standard Deviation 48.46	-72.1 Percentage change Standard Deviation 35.97
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Scaling at week 4	-62.2 Percentage change Standard Deviation 30.65	-64.9 Percentage change Standard Deviation 34.27
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Scaling at week 8	-74.9 Percentage change Standard Deviation 38.02	-75.1 Percentage change Standard Deviation 30.50
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Scaling at week 12	-76.5 Percentage change Standard Deviation 29.91	-76.9 Percentage change Standard Deviation 31.93
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Scaling at week 16	-74.3 Percentage change Standard Deviation 40.92	-77.2 Percentage change Standard Deviation 32.84
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Scaling at week 20	-76.4 Percentage change Standard Deviation 31.93	-76.2 Percentage change Standard Deviation 36.76
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Scaling at week 24	-75.4 Percentage change Standard Deviation 35.21	-78.2 Percentage change Standard Deviation 33.38
Percentage Change From Baseline in Participant's Self-assessed Pain, Itching and Scaling Scaling at week 28	-74.3 Percentage change Standard Deviation 36.50	-77.7 Percentage change Standard Deviation 35.84

Adverse Events

Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.)

Serious events: 18 serious events

Other events: 178 other events

Deaths: 2 deaths

Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention

Serious events: 20 serious events

Other events: 204 other events

Deaths: 0 deaths

Extension Period: Lifestyle Intervention

Serious events: 11 serious events

Other events: 101 other events

Deaths: 0 deaths

Extension Period: Lifestyle Intervention + Secukinumab

Serious events: 10 serious events

Other events: 103 other events

Deaths: 0 deaths

Extension Period: Secukinumab

Serious events: 32 serious events

Other events: 225 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=371 participants at risk All adverse events (AEs) from baseline (BL) until Week 28 were collected for participants randomized to Arm A, who received Secukinumab 300 mg s.c. administered as two 150 mg prefilled syringe injections at Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, and 24 (last injection at Week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=409 participants at risk All adverse events (AEs) from baseline (BL) until Week 28 were collected for participants randomized to Arm B, who received Secukinumab 300 mg s.c. administered as two 150 mg prefilled syringe injections at Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, and 24 (last injection at Week 24), and who additionally participated in a lifestyle intervention program.	Extension Period: Lifestyle Intervention n=189 participants at risk All adverse events (AEs) from baseline (BL) until Week 36 were collected for participants who moved to this arm at Week 28 (including AEs reported from BL through Week 28). This arm included all participants from the Core Study who either switched to or continued with Lifestyle Intervention only during the Extension Period. The lifestyle intervention was a structured and standardized program aimed at improving metabolic status and promoting weight loss and was not considered study treatment.	Extension Period: Lifestyle Intervention + Secukinumab n=164 participants at risk All adverse events (AEs) from baseline (BL) until Week 36 were collected for participants who moved to this arm at Week 28 (including AEs reported from BL through Week 28). This arm included all participants from the Core Study who either continued Secukinumab and initiated lifestyle intervention during the Extension Period, or who continued both Secukinumab and lifestyle intervention during the Extension Period.	Extension Period: Secukinumab n=427 participants at risk All adverse events (AEs) from baseline (BL) until Week 36 were collected for participants who moved to this arm at Week 28 (including AEs reported from BL through Week 28). This arm included all participants from the Core Study who either switched to or continued on Secukinumab only during the Extension Period, as well as participants who did not enter the Extension Period.
Cardiac disorders Coronary artery disease	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Cardiac disorders Atrial fibrillation	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.47% 2/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Cardiac disorders Myocardial infarction	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.47% 2/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Cardiac disorders Pericarditis	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.61% 1/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Endocrine disorders Goitre	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.61% 1/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Eye disorders Endocrine ophthalmopathy	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Eye disorders Macular oedema	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Eye disorders Ocular fistula	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Eye disorders Ulcerative keratitis	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.53% 1/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Gastrointestinal disorders Femoral hernia	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Gastrointestinal disorders Gastrointestinal polyp	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.53% 1/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Gastrointestinal disorders Hiatus hernia	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Gastrointestinal disorders Hypertrophy of tongue papillae	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.53% 1/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Gastrointestinal disorders Inguinal hernia	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Gastrointestinal disorders Oesophagitis	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
General disorders Chest discomfort	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
General disorders Oedema peripheral	0.54% 2/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.47% 2/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
General disorders Pyrexia	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Immune system disorders Drug hypersensitivity	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Infections and infestations Bronchiolitis	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Infections and infestations Erysipelas	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.47% 2/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Infections and infestations Gastrointestinal infection	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Infections and infestations Otitis media	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Infections and infestations Pulpitis dental	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.61% 1/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Infections and infestations Tonsillitis	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.61% 1/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Infections and infestations Upper respiratory tract infection	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.61% 1/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Infections and infestations Urinary tract infection	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.53% 1/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Infections and infestations Vestibular neuronitis	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Injury, poisoning and procedural complications Concussion	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Injury, poisoning and procedural complications Fall	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.53% 1/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Investigations Alanine aminotransferase increased	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Injury, poisoning and procedural complications Foot fracture	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Injury, poisoning and procedural complications Head injury	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Injury, poisoning and procedural complications Pulmonary contusion	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Injury, poisoning and procedural complications Reactive gastropathy	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.61% 1/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.53% 1/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Injury, poisoning and procedural complications Tendon rupture	0.54% 2/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.47% 2/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Investigations Aspartate aminotransferase increased	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Investigations Gamma-glutamyltransferase increased	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Metabolism and nutrition disorders Hypercalcaemia	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Nervous system disorders Cerebral infarction	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.53% 1/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.54% 2/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.61% 1/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.70% 3/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.53% 1/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.53% 1/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.61% 1/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Scrotal cancer	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral cancer	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Nervous system disorders Cerebral haemorrhage	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Nervous system disorders Dizziness	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Nervous system disorders Paraesthesia	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Product Issues Device loosening	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Psychiatric disorders Mania	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Renal and urinary disorders Nephrolithiasis	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.53% 1/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.61% 1/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Renal and urinary disorders Renal failure	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Reproductive system and breast disorders Cystocele	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.53% 1/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.61% 1/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.81% 3/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.61% 1/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.94% 4/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Skin and subcutaneous tissue disorders Erythrodermic psoriasis	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Skin and subcutaneous tissue disorders Psoriasis	0.54% 2/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.53% 1/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.70% 3/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Vascular disorders Arteriovenous fistula	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Vascular disorders Circulatory collapse	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.61% 1/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Vascular disorders Flushing	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Vascular disorders Hypertension	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.23% 1/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.53% 1/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Vascular disorders Peripheral ischaemia	0.00% 0/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.61% 1/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Vascular disorders Varicose vein	0.27% 1/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.24% 1/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	1.2% 2/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	0.00% 0/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.

Other adverse events

Other adverse events
Measure	Core Study/Arm A: Secukinumab 300 mg Subcutaneous (s.c.) n=371 participants at risk All adverse events (AEs) from baseline (BL) until Week 28 were collected for participants randomized to Arm A, who received Secukinumab 300 mg s.c. administered as two 150 mg prefilled syringe injections at Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, and 24 (last injection at Week 24).	Core Study/Arm B: Secukinumab 300 mg Subcutaneous (s.c.) and Lifestyle Intervention n=409 participants at risk All adverse events (AEs) from baseline (BL) until Week 28 were collected for participants randomized to Arm B, who received Secukinumab 300 mg s.c. administered as two 150 mg prefilled syringe injections at Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, and 24 (last injection at Week 24), and who additionally participated in a lifestyle intervention program.	Extension Period: Lifestyle Intervention n=189 participants at risk All adverse events (AEs) from baseline (BL) until Week 36 were collected for participants who moved to this arm at Week 28 (including AEs reported from BL through Week 28). This arm included all participants from the Core Study who either switched to or continued with Lifestyle Intervention only during the Extension Period. The lifestyle intervention was a structured and standardized program aimed at improving metabolic status and promoting weight loss and was not considered study treatment.	Extension Period: Lifestyle Intervention + Secukinumab n=164 participants at risk All adverse events (AEs) from baseline (BL) until Week 36 were collected for participants who moved to this arm at Week 28 (including AEs reported from BL through Week 28). This arm included all participants from the Core Study who either continued Secukinumab and initiated lifestyle intervention during the Extension Period, or who continued both Secukinumab and lifestyle intervention during the Extension Period.	Extension Period: Secukinumab n=427 participants at risk All adverse events (AEs) from baseline (BL) until Week 36 were collected for participants who moved to this arm at Week 28 (including AEs reported from BL through Week 28). This arm included all participants from the Core Study who either switched to or continued on Secukinumab only during the Extension Period, as well as participants who did not enter the Extension Period.
Investigations Alanine aminotransferase increased	2.7% 10/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	1.7% 7/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	1.1% 2/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	5.5% 9/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	2.1% 9/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Musculoskeletal and connective tissue disorders Arthralgia	3.0% 11/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	9.8% 40/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	9.5% 18/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	11.6% 19/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	4.4% 19/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Musculoskeletal and connective tissue disorders Back pain	6.2% 23/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	5.4% 22/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	10.1% 19/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	5.5% 9/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	5.4% 23/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Nervous system disorders Headache	10.8% 40/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	8.8% 36/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	9.5% 18/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	12.2% 20/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	9.4% 40/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.6% 6/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	3.9% 16/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	1.6% 3/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	5.5% 9/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	2.6% 11/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Skin and subcutaneous tissue disorders Pruritus	4.3% 16/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	4.2% 17/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	1.6% 3/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	8.5% 14/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	5.2% 22/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Skin and subcutaneous tissue disorders Psoriasis	4.6% 17/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	4.4% 18/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	10.1% 19/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	11.6% 19/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	8.7% 37/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Vascular disorders Hypertension	5.1% 19/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	3.9% 16/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	4.8% 9/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	5.5% 9/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	4.7% 20/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
General disorders Fatigue	3.8% 14/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	2.4% 10/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	1.1% 2/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	5.5% 9/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	3.7% 16/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Infections and infestations Nasopharyngitis	22.4% 83/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	23.5% 96/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	21.7% 41/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	29.9% 49/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	25.3% 108/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.
Gastrointestinal disorders Diarrhoea	5.1% 19/371 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	5.4% 22/409 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	7.4% 14/189 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	6.1% 10/164 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.	5.4% 23/427 • On-treatment adverse events and deaths were reported from Baseline (first dose of study treatment) in the Core Study through 12 weeks after the last dose of study treatment in the Core Study (corresponding to Week 36 of the Extension Period), with assessments conducted for up to approximately 56 weeks. Any sign or symptom that occurred during the conduct of the trial and safety follow-up. The Safety Set included all subjects who received at least one dose of study treatment in the Core Study.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER