Trial Outcomes & Findings for 16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis (NCT NCT02294227)

Last Updated: 2019-07-02

Results Overview

The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Disability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

341 participants

Primary outcome timeframe

16 weeks

Results posted on

2019-07-02

Participant Flow

There were 341 patients originally randomized to one of 2 trearment groups. Seven placebo patients discontinued before week 16 and therefore not switched to treatment. Only 334 patients received secukinumab treatment.

Patients were randomized 1:1:1.

Participant milestones

Participant milestones
Measure	Secukinumab 150 mg Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Secukinumab 150 mg No Load Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Placebo Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
Overall Study STARTED	114	113	114
Overall Study COMPLETED	89	88	95
Overall Study NOT COMPLETED	25	25	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Secukinumab 150 mg Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Secukinumab 150 mg No Load Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Placebo Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
Overall Study Death	0	0	1
Overall Study Subject/Guardian Decision	6	3	7
Overall Study Physician Decision	1	2	1
Overall Study Lost to Follow-up	1	0	0
Overall Study Lack of Efficacy	11	12	8
Overall Study Adverse Event	6	8	2

Baseline Characteristics

16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Secukinumab 150 mg n=114 Participants Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Secukinumab 150 mg No Load n=113 Participants Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Placebo n=107 Participants Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Total n=334 Participants Total of all reporting groups
Age, Continuous	48.3 Years STANDARD_DEVIATION 12.17 • n=93 Participants	50.4 Years STANDARD_DEVIATION 11.78 • n=4 Participants	48.5 Years STANDARD_DEVIATION 12.12 • n=27 Participants	49.0 Years STANDARD_DEVIATION 12.03 • n=483 Participants
Sex: Female, Male Female	47 Participants n=93 Participants	51 Participants n=4 Participants	43 Participants n=27 Participants	141 Participants n=483 Participants
Sex: Female, Male Male	67 Participants n=93 Participants	62 Participants n=4 Participants	64 Participants n=27 Participants	193 Participants n=483 Participants
Race/Ethnicity, Customized Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized White	113 Participants n=93 Participants	113 Participants n=4 Participants	107 Participants n=27 Participants	333 Participants n=483 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg n=114 Participants Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Secukinumab 150 mg No Load n=113 Participants Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Placebo n=114 Participants Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
Number of Participants With American College of Rheumatology 20 (ACR20) Response	47 Participants	45 Participants	21 Participants

SECONDARY outcome

Timeframe: week 16

Population: Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned.

DAS28-CRP score change from baseline using MMRM up to Week 16. DAS-CRP values range between 2.0 and 10. The higher the score, the higher the disease severity. n: Number of subjects with measures at both baseline and the corresponding post baseline visit.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg n=114 Participants Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Secukinumab 150 mg No Load n=113 Participants Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Placebo n=114 Participants Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
Disease Activity Score (DAS-C28-CRP) Score Change From Baseline Using MMRM at Week 16	-0.98 scores Standard Error 0.106	-0.84 scores Standard Error 0.106	-0.21 scores Standard Error 0.107

SECONDARY outcome

Timeframe: 16 weeks

Population: The psoriasis subset included all full analysis set (FAS) patients who had ≥3% of the body surface area (BSA) affected by psoriatic skin involvement at baseline.

PASI is a measure of disease activity based on extent of the disease, severity of erythema, scaling and thickness in different body areas affected by psoriasis. PASI75 is an improvement in the PASI score of at least 75% compared to baseline. PASI75 is used to assess the efficacy of secukinumab, with or without loading, versus placebo. PASI75 response using non-responder imputation and rescue penalty up to Week 16

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg n=55 Participants Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Secukinumab 150 mg No Load n=54 Participants Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Placebo n=62 Participants Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
Psoriatic Area and Severity Index 75 (PASI75)	29 Participants Interval 4.9 to 42.38	27 Participants Interval 4.14 to 35.19	5 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned.

SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg n=114 Participants Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Secukinumab 150 mg No Load n=113 Participants Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Placebo n=77 Participants Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
Short Form Health Survey Physical Component Score (SF-36-PCS)	3.42 scores on a scale Standard Error 0.5676	3.44 scores on a scale Standard Error 0.5678	0.63 scores on a scale Standard Error 0.586

SECONDARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned.

The ACR50 response is defined by at least 50% decrease in the swollen and tender joint count, and at least 50% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]. ACR50 is used to assess the efficacy of secukinumab, with or without loading, versus placebo. This table is the ACR50 response using non-responder imputation and rescue penalty up to Week 16

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg n=114 Participants Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Secukinumab 150 mg No Load n=113 Participants Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Placebo n=114 Participants Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
Number of Participants With American College of Rheumatology 50 (ACR50)	26 Participants	19 Participants	7 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned.

The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Diability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant \[either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)\]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo

Outcome measures

Outcome measures
Measure	Secukinumab 150 mg n=114 Participants Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Secukinumab 150 mg No Load n=113 Participants Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator	Placebo n=114 Participants Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
Number of Participants With American College of Rheumatology 20 (ACR20) Response	33 Participants	26 Participants	22 Participants

Adverse Events

Any AIN457 150 mg

Serious events: 47 serious events

Other events: 252 other events

Deaths: 1 deaths

Any AIN457 300 mg

Serious events: 12 serious events

Other events: 89 other events

Deaths: 1 deaths

Any AIN457

Serious events: 59 serious events

Other events: 267 other events

Deaths: 2 deaths

Placebo

Serious events: 5 serious events

Other events: 61 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Disclosure Office

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 (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Any AIN457 150 mg n=334 participants at risk Any AIN457 150 mg	Any AIN457 300 mg n=136 participants at risk Any AIN457 300 mg	Any AIN457 n=334 participants at risk Any AIN457	Placebo n=114 participants at risk Placebo
Cardiac disorders Acute myocardial infarction	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Cardiac disorders Coronary artery disease	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Cardiac disorders Myocardial infarction	0.60% 2/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.60% 2/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Cardiac disorders Myocardial ischaemia	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Endocrine disorders Goitre	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Gastrointestinal disorders Abdominal hernia	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Gastrointestinal disorders Colitis ulcerative	0.00% 0/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Gastrointestinal disorders Crohn's disease	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Gastrointestinal disorders Inguinal hernia	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Gastrointestinal disorders Pancreatitis acute	0.00% 0/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
General disorders Non-cardiac chest pain	0.00% 0/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Hepatobiliary disorders Biliary colic	0.00% 0/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Hepatobiliary disorders Cholelithiasis	0.00% 0/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Hepatobiliary disorders Drug-induced liver injury	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Hepatobiliary disorders Hepatitis alcoholic	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Immune system disorders Immunosuppression	0.00% 0/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Product Issues Device dislocation	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Atypical pneumonia	0.00% 0/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Bacterial pyelonephritis	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Campylobacter gastroenteritis	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Erysipelas	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Escherichia urinary tract infection	0.00% 0/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Gastroenteritis	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Hepatitis A	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Influenza	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Pilonidal cyst	0.00% 0/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Pyelonephritis	0.00% 0/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Sepsis	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Urinary tract infection	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Urosepsis	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Viral upper respiratory tract infection	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Injury, poisoning and procedural complications Fall	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Injury, poisoning and procedural complications Joint dislocation	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Injury, poisoning and procedural complications Laceration	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Injury, poisoning and procedural complications Post procedural haemorrhage	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.60% 2/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Injury, poisoning and procedural complications Rib fracture	0.60% 2/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.60% 2/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Injury, poisoning and procedural complications Tendon rupture	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.60% 2/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Injury, poisoning and procedural complications Thermal burn	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Injury, poisoning and procedural complications Tibia fracture	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Injury, poisoning and procedural complications Upper limb fracture	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.30% 1/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm

Other adverse events
Measure	Any AIN457 150 mg n=334 participants at risk Any AIN457 150 mg	Any AIN457 300 mg n=136 participants at risk Any AIN457 300 mg	Any AIN457 n=334 participants at risk Any AIN457	Placebo n=114 participants at risk Placebo
Infections and infestations Upper respiratory tract infection	14.4% 48/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	8.1% 11/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	16.5% 55/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	5.3% 6/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Urinary tract infection	5.1% 17/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	5.4% 18/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.5% 4/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Viral infection	1.8% 6/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.5% 2/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.4% 8/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Viral upper respiratory tract infection	3.3% 11/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.5% 2/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.9% 13/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Blood and lymphatic system disorders Leukopenia	2.7% 9/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.2% 3/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.6% 12/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Cardiac disorders Ventricular extrasystoles	0.90% 3/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.2% 3/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.8% 6/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Ear and labyrinth disorders Vertigo	2.4% 8/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.7% 9/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Gastrointestinal disorders Abdominal pain	3.0% 10/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.3% 11/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Gastrointestinal disorders Diarrhoea	8.7% 29/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.9% 4/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	9.6% 32/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.6% 3/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Gastrointestinal disorders Dyspepsia	1.8% 6/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.2% 3/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.7% 9/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Gastrointestinal disorders Nausea	5.7% 19/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.5% 2/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	6.3% 21/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	5.3% 6/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Gastrointestinal disorders Toothache	0.90% 3/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.2% 3/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.5% 5/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Gastrointestinal disorders Vomiting	2.4% 8/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.5% 2/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.0% 10/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
General disorders Fatigue	3.9% 13/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.2% 3/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	4.8% 16/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.8% 2/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
General disorders Oedema peripheral	1.5% 5/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.5% 2/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.1% 7/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
General disorders Pyrexia	3.3% 11/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.6% 12/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Hepatobiliary disorders Hepatic steatosis	1.8% 6/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.5% 2/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.4% 8/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Bronchitis	9.3% 31/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	5.9% 8/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	11.4% 38/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.8% 2/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Cystitis	2.1% 7/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.2% 3/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.0% 10/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Furuncle	1.8% 6/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.1% 7/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Gastroenteritis	4.5% 15/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.7% 5/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	5.7% 19/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.6% 3/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Gastroenteritis viral	2.1% 7/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.4% 8/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Gingivitis	1.8% 6/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.1% 7/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.8% 2/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Influenza	3.3% 11/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.9% 4/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	4.2% 14/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.8% 2/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Laryngitis	1.5% 5/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.2% 3/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.4% 8/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Nasopharyngitis	25.7% 86/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	15.4% 21/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	28.7% 96/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	14.0% 16/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Oral herpes	3.3% 11/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.9% 4/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.9% 13/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.6% 3/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Pharyngitis	6.9% 23/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.9% 4/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	7.5% 25/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Pulpitis dental	2.4% 8/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.5% 2/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.0% 10/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Respiratory tract infection	3.0% 10/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.5% 2/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.3% 11/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.8% 2/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Rhinitis	2.7% 9/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.7% 5/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	4.2% 14/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Sinusitis	8.7% 29/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	8.1% 11/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	10.2% 34/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Infections and infestations Tonsillitis	3.0% 10/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	4.4% 6/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	4.2% 14/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Injury, poisoning and procedural complications Contusion	3.0% 10/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.3% 11/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Injury, poisoning and procedural complications Fall	3.3% 11/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.5% 2/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.9% 13/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Injury, poisoning and procedural complications Limb injury	3.0% 10/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.3% 11/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Investigations Alanine aminotransferase increased	2.1% 7/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.4% 8/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Investigations Hepatic enzyme increased	1.8% 6/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	1.5% 2/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.4% 8/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.00% 0/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Investigations Weight increased	1.8% 6/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.1% 7/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.88% 1/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm
Metabolism and nutrition disorders Dyslipidaemia	2.7% 9/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	0.74% 1/136 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	2.7% 9/334 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm	3.5% 4/114 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately week 112 Safety analysis is based on actual dose received. Pts who escalated from 150mg to 300mg are also analyzed at escalated dose Any AIN457 150 mg (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 (n = 334): 114 AIN150 Load + 113 AIN150 No Load + 107 PBO-AIN150 Any AIN457 300mg (n=136): 46 up-titrators from AIN150 load + 45 up-titrators from AIN150 No Load + 45 up-titrators from PBO - AIN300 Placebo (n=114): 114 patients were randomized to the placebo arm