Trial Outcomes & Findings for Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS) (NCT NCT03713632)

Last Updated: 2024-10-09

Results Overview

HiSCR50 at Week 16 is defined as at least a 50% decrease in Abscess and inflammatory Nodule (AN) count compared to baseline with no increase in the number of abscesses and/or in the number of draining fistulas from baseline to Week 16. The baseline is defined as the last assessment (including unscheduled visits) obtained before/on the day of the first administration of the study treatment, or on the randomization date if there had been no drug administration. This endpoint was analyzed by logistic regression.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

545 participants

Primary outcome timeframe

16 weeks

Results posted on

2024-10-09

Participant Flow

Participants enrolled in 132 study sites worldwide.

Participant milestones

Participant milestones
Measure	AIN457 Q2W Secukinumab 300mg every 2 weeks (Treatment Period 1 and 2)	AIN457 Q4W Secukinumab 300mg every 4 weeks (Treatment Period 1 and 2)	Placebo Placebo group to secukinumab 300mg (Treatment Period 1)	Placebo - Re-randomized to AIN457 Q2W Placebo group, re-randomized to secukinumab 300mg Q2W at week 16 (Treatment Period 2)	Placebo - Re-randomized to AIN457 Q4W Placebo group, re-randomized to secukinumab 300mg Q4W at week 16 (Treatment Period 2)
Treatment Period 1 (Until Week 16) STARTED	181	180	183	0	0
Treatment Period 1 (Until Week 16) Full Analysis Set	180	180	183	0	0
Treatment Period 1 (Until Week 16) COMPLETED	170	169	167	0	0
Treatment Period 1 (Until Week 16) NOT COMPLETED	11	11	16	0	0
Treatment Period 2 (After Week 16) STARTED	170	169	0	81	86
Treatment Period 2 (After Week 16) COMPLETED	149	133	0	68	69
Treatment Period 2 (After Week 16) NOT COMPLETED	21	36	0	13	17

Reasons for withdrawal

Reasons for withdrawal
Measure	AIN457 Q2W Secukinumab 300mg every 2 weeks (Treatment Period 1 and 2)	AIN457 Q4W Secukinumab 300mg every 4 weeks (Treatment Period 1 and 2)	Placebo Placebo group to secukinumab 300mg (Treatment Period 1)	Placebo - Re-randomized to AIN457 Q2W Placebo group, re-randomized to secukinumab 300mg Q2W at week 16 (Treatment Period 2)	Placebo - Re-randomized to AIN457 Q4W Placebo group, re-randomized to secukinumab 300mg Q4W at week 16 (Treatment Period 2)
Treatment Period 1 (Until Week 16) Withdrawal by Subject	6	6	8	0	0
Treatment Period 1 (Until Week 16) Adverse Event	1	4	4	0	0
Treatment Period 1 (Until Week 16) Lost to Follow-up	1	1	1	0	0
Treatment Period 1 (Until Week 16) Lack of Efficacy	1	0	1	0	0
Treatment Period 1 (Until Week 16) Technical problems	1	0	1	0	0
Treatment Period 1 (Until Week 16) Pregnancy	0	0	1	0	0
Treatment Period 1 (Until Week 16) Misrandomized Subject	1	0	0	0	0
Treatment Period 2 (After Week 16) Withdrawal by Subject	9	18	0	9	12
Treatment Period 2 (After Week 16) Adverse Event	6	3	0	2	1
Treatment Period 2 (After Week 16) Lack of Efficacy	3	3	0	1	2
Treatment Period 2 (After Week 16) Lost to Follow-up	1	8	0	1	0
Treatment Period 2 (After Week 16) Physician Decision	1	2	0	0	2
Treatment Period 2 (After Week 16) Technical Problems	1	0	0	0	0
Treatment Period 2 (After Week 16) Death	0	1	0	0	0
Treatment Period 2 (After Week 16) Pregnancy	0	1	0	0	0

Baseline Characteristics

Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AIN457 Q2W n=180 Participants Secukinumab 300mg every 2 weeks	AIN457 Q4W n=180 Participants Secukinumab 300mg every 4 weeks	Placebo n=183 Participants Placebo group to secukinumab 300mg	Total n=543 Participants Total of all reporting groups
Age, Continuous	37.3 Years STANDARD_DEVIATION 11.48 • n=99 Participants	35.5 Years STANDARD_DEVIATION 11.41 • n=107 Participants	36.2 Years STANDARD_DEVIATION 11.25 • n=206 Participants	36.3 Years STANDARD_DEVIATION 11.38 • n=7 Participants
Age, Customized Between 18 and 65 years	177 participants n=99 Participants	178 participants n=107 Participants	181 participants n=206 Participants	536 participants n=7 Participants
Age, Customized >=65 years	3 participants n=99 Participants	2 participants n=107 Participants	2 participants n=206 Participants	7 participants n=7 Participants
Sex: Female, Male Female	98 Participants n=99 Participants	103 Participants n=107 Participants	105 Participants n=206 Participants	306 Participants n=7 Participants
Sex: Female, Male Male	82 Participants n=99 Participants	77 Participants n=107 Participants	78 Participants n=206 Participants	237 Participants n=7 Participants
Race/Ethnicity, Customized White	133 Participants n=99 Participants	139 Participants n=107 Participants	143 Participants n=206 Participants	415 Participants n=7 Participants
Race/Ethnicity, Customized Black or African American	18 Participants n=99 Participants	19 Participants n=107 Participants	12 Participants n=206 Participants	49 Participants n=7 Participants
Race/Ethnicity, Customized Asian	16 Participants n=99 Participants	16 Participants n=107 Participants	19 Participants n=206 Participants	51 Participants n=7 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Race/Ethnicity, Customized American Indian or Alaska native	7 Participants n=99 Participants	5 Participants n=107 Participants	8 Participants n=206 Participants	20 Participants n=7 Participants
Race/Ethnicity, Customized Multiple	4 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	6 Participants n=7 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Full analysis set (FAS): consisted of all subjects to whom study treatment had been assigned, excluding mis-randomized patients. Subjects were analyzed according to the treatment assigned at randomization.

Outcome measures

Outcome measures
Measure	AIN457 Q2W n=180 Participants Secukinumab 300mg every 2 weeks	AIN457 Q4W n=180 Participants Secukinumab 300mg every 4 weeks	Placebo n=183 Participants Placebo group to secukinumab 300mg
Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR50)	42.3 Percentage of Participants	46.1 Percentage of Participants	31.2 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Full Analysis Set

Percent change from baseline in abscesses and inflammatory nodules (AN) count. This endpoint was analyzed by analysis of covariance.

Outcome measures

Outcome measures
Measure	AIN457 Q2W n=180 Participants Secukinumab 300mg every 2 weeks	AIN457 Q4W n=180 Participants Secukinumab 300mg every 4 weeks	Placebo n=183 Participants Placebo group to secukinumab 300mg
Percentage Change From Baseline in AN Count	-39.3 Percentage change from baseline Standard Error 4.43	-45.5 Percentage change from baseline Standard Error 4.08	-22.4 Percentage change from baseline Standard Error 4.84

SECONDARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set

Percentage of participants who experience at least one flare over 16 weeks. A flare is defined as at least a 25% increase in abscesses and inflammatory nodules (AN) count with a minimum increase of 2 AN relative to baseline. This endpoint was analyzed by logistic regression.

Outcome measures

Outcome measures
Measure	AIN457 Q2W n=180 Participants Secukinumab 300mg every 2 weeks	AIN457 Q4W n=180 Participants Secukinumab 300mg every 4 weeks	Placebo n=183 Participants Placebo group to secukinumab 300mg
Percentage of Participants With Hidradenitis Suppurativa (HS) Flares	20.1 Percentage of Participants	15.6 Percentage of Participants	27.0 Percentage of Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set restricted to participants with baseline NRS score greater or equal to 3

Patients achieving Numerical Rating Scale score of 30 (NRS30) at week 16, defined as at least a 30% reduction and at least one unit reduction from baseline in the Patient's Global assessment of Skin Pain (where range 0 \[no skin pain\] to 10 \[worst skin pain\]). This endpoint was analyzed by logistic regression.

Outcome measures

Outcome measures
Measure	AIN457 Q2W n=135 Participants Secukinumab 300mg every 2 weeks	AIN457 Q4W n=129 Participants Secukinumab 300mg every 4 weeks	Placebo n=132 Participants Placebo group to secukinumab 300mg
Percentage of Participants Achieving NRS30	38.6 Percentage of participants	34.7 Percentage of participants	22.4 Percentage of participants

Adverse Events

AIN457 Q2W

Serious events: 19 serious events

Other events: 123 other events

Deaths: 0 deaths

AIN457 Q4W

Serious events: 15 serious events

Other events: 125 other events

Deaths: 1 deaths

Placebo

Serious events: 5 serious events

Other events: 84 other events

Deaths: 0 deaths

Any AIN457 Q2W

Serious events: 22 serious events

Other events: 174 other events

Deaths: 0 deaths

Any AIN457 Q4W

Serious events: 23 serious events

Other events: 174 other events

Deaths: 2 deaths

Any AIN457

Serious events: 45 serious events

Other events: 348 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	AIN457 Q2W n=180 participants at risk Subjects who were randomized to AIN457 (secukinumab) 300mg Q2W dose regimen at the study entry. Adverse events were assessed up to Week 60	AIN457 Q4W n=180 participants at risk Subjects who were randomized to AIN457 (secukinumab) 300mg Q4W dose regimen at the study entry. Adverse events were assessed up to Week 60	Placebo n=183 participants at risk Subjects who were randomized to matching placebo at the study entry. Adverse events were assessed up to Week 16	Any AIN457 Q2W n=261 participants at risk Subjects who received at least 1 dose of secukinumab 300 mg Q2W dose (including subjects who switched from placebo to secukinumab Q2W at Week 16). Adverse events were assessed up to Week 60	Any AIN457 Q4W n=266 participants at risk Subjects who received at least 1 dose of secukinumab 300 mg Q4W dose (including subjects who switched from placebo to secukinumab Q4W at Week 16). Adverse events were assessed up to Week 60	Any AIN457 n=527 participants at risk Subjects who received at least 1 dose of secukinumab
Cardiac disorders Arrhythmia	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Cardiac disorders Myocardial infarction	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Colitis ulcerative	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Inflammatory bowel disease	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
General disorders Pyrexia	1.1% 2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.77% 2/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 2/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
General disorders Systemic inflammatory response syndrome	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
General disorders Unevaluable event	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Hepatobiliary disorders Cholecystitis	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Hepatobiliary disorders Cholecystitis acute	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Hepatobiliary disorders Cholelithiasis	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Immune system disorders Amyloidosis	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Abscess	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Abscess limb	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations COVID-19 pneumonia	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Cellulitis	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Clostridium difficile colitis	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Colonic abscess	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Dermatitis infected	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Enterocolitis infectious	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Injection site abscess	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Localised infection	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Otitis externa	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Pyelonephritis	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Scrotal infection	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Soft tissue infection	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Sweat gland infection	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 2/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Urinary tract infection	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Injury, poisoning and procedural complications Lower limb fracture	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 2/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.75% 2/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 2/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Musculoskeletal and connective tissue disorders Muscle spasms	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Nervous system disorders Sciatica	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Psychiatric disorders Confusional state	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Psychiatric disorders Depression	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Psychiatric disorders Obsessive-compulsive disorder	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Renal and urinary disorders Acute kidney injury	1.1% 2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.77% 2/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 2/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Renal and urinary disorders Glomerular vascular disorder	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Renal and urinary disorders Nephrolithiasis	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 2/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Renal and urinary disorders Pelvi-ureteric obstruction	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Reproductive system and breast disorders Scrotal inflammation	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Skin and subcutaneous tissue disorders Hidradenitis	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.95% 5/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Vascular disorders Hypotension	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.19% 1/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.

Other adverse events

Other adverse events
Measure	AIN457 Q2W n=180 participants at risk Subjects who were randomized to AIN457 (secukinumab) 300mg Q2W dose regimen at the study entry. Adverse events were assessed up to Week 60	AIN457 Q4W n=180 participants at risk Subjects who were randomized to AIN457 (secukinumab) 300mg Q4W dose regimen at the study entry. Adverse events were assessed up to Week 60	Placebo n=183 participants at risk Subjects who were randomized to matching placebo at the study entry. Adverse events were assessed up to Week 16	Any AIN457 Q2W n=261 participants at risk Subjects who received at least 1 dose of secukinumab 300 mg Q2W dose (including subjects who switched from placebo to secukinumab Q2W at Week 16). Adverse events were assessed up to Week 60	Any AIN457 Q4W n=266 participants at risk Subjects who received at least 1 dose of secukinumab 300 mg Q4W dose (including subjects who switched from placebo to secukinumab Q4W at Week 16). Adverse events were assessed up to Week 60	Any AIN457 n=527 participants at risk Subjects who received at least 1 dose of secukinumab
Gastrointestinal disorders Abdominal pain	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.9% 7/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 2/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.8% 10/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.8% 15/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Abdominal pain upper	1.7% 3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	5.0% 9/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 4/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.8% 10/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.7% 14/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Constipation	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 2/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 4/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.95% 5/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Dental caries	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 4/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.95% 5/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Diarrhoea	7.2% 13/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	7.8% 14/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	7.1% 13/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	7.3% 19/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	7.1% 19/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	7.2% 38/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.7% 7/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 6/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.5% 13/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Haemorrhoids	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.8% 5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 6/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Nausea	3.3% 6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.8% 5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	4.6% 12/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.6% 7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.6% 19/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Toothache	3.3% 6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.8% 5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.7% 7/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 12/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Gastrointestinal disorders Vomiting	1.1% 2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 6/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.3% 7/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
General disorders Fatigue	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.3% 6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 2/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.7% 7/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.6% 7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.7% 14/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
General disorders Influenza like illness	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.8% 5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 6/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
General disorders Pyrexia	3.9% 7/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	4.4% 8/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.6% 3/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.4% 9/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	4.5% 12/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	4.0% 21/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Bronchitis	2.8% 5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.8% 5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 2/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.6% 7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 12/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations COVID-19	5.6% 10/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.9% 7/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.6% 3/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	5.0% 13/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	5.3% 14/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	5.1% 27/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Conjunctivitis	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.3% 6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 4/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.6% 7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.1% 11/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Ear infection	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 6/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Folliculitis	5.0% 9/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.6% 3/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.4% 9/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 4/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.5% 13/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Influenza	2.8% 5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.7% 7/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 8/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Nasopharyngitis	11.7% 21/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	10.0% 18/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	8.7% 16/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	10.7% 28/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	9.4% 25/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	10.1% 53/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Oral candidiasis	2.8% 5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 3/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 8/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Pharyngitis	1.7% 3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.3% 6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.6% 3/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 4/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.4% 9/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.5% 13/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Rhinitis	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 6/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.6% 7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.5% 13/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Sinusitis	1.7% 3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.7% 3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.6% 3/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.7% 7/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 3/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 10/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Skin candida	3.3% 6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.1% 8/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 4/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 12/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Sweat gland infection	1.7% 3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.6% 3/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.4% 9/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.75% 2/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.1% 11/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Tonsillitis	1.1% 2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 4/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.7% 9/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Upper respiratory tract infection	7.2% 13/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	4.4% 8/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.8% 7/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	6.1% 16/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	4.1% 11/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	5.1% 27/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Infections and infestations Urinary tract infection	3.9% 7/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.9% 7/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.7% 5/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.1% 8/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	4.5% 12/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.8% 20/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Injury, poisoning and procedural complications Ligament sprain	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 6/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Investigations Gamma-glutamyltransferase increased	2.8% 5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.56% 1/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.38% 1/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 6/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Investigations Lipase increased	1.7% 3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.9% 7/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.6% 7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 12/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Investigations SARS-CoV-2 test positive	1.7% 3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.6% 3/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 4/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.7% 9/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Investigations Weight decreased	0.00% 0/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 4/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.76% 4/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Musculoskeletal and connective tissue disorders Arthralgia	3.9% 7/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.7% 5/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	4.2% 11/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.4% 9/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.8% 20/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Musculoskeletal and connective tissue disorders Back pain	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	6.7% 12/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.7% 7/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	5.3% 14/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	4.0% 21/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Musculoskeletal and connective tissue disorders Myalgia	1.7% 3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.6% 3/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 4/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 6/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 10/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Nervous system disorders Dizziness	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.9% 7/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.6% 3/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 6/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.6% 7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.5% 13/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Nervous system disorders Headache	17.2% 31/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	15.0% 27/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	8.7% 16/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	14.9% 39/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	13.5% 36/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	14.2% 75/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Psychiatric disorders Depression	3.3% 6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.8% 5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 6/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.1% 11/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Reproductive system and breast disorders Dysmenorrhoea	1.1% 2/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.8% 5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 3/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 8/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Respiratory, thoracic and mediastinal disorders Cough	2.8% 5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.9% 7/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.6% 3/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 6/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.4% 9/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.8% 15/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.4% 8/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	4.4% 8/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.1% 8/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.4% 9/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.2% 17/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Skin and subcutaneous tissue disorders Dermatitis	1.7% 3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 4/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 4/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.5% 8/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Skin and subcutaneous tissue disorders Eczema	5.6% 10/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.3% 6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.55% 1/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	4.2% 11/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.6% 7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.4% 18/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Skin and subcutaneous tissue disorders Hidradenitis	11.7% 21/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	12.8% 23/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	7.7% 14/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	10.0% 26/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	11.7% 31/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	10.8% 57/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Skin and subcutaneous tissue disorders Intertrigo	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.8% 5/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 6/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.0% 8/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.7% 14/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Skin and subcutaneous tissue disorders Pruritus	4.4% 8/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.7% 3/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.7% 5/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	4.2% 11/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.9% 5/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.0% 16/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Skin and subcutaneous tissue disorders Psoriasis	3.3% 6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.2% 4/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	0.00% 0/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 6/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 6/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.3% 12/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.
Vascular disorders Hypertension	6.1% 11/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	3.3% 6/180 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	1.1% 2/183 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	5.4% 14/261 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	2.6% 7/266 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.	4.0% 21/527 • Adverse events (AEs) were reported from first dose of study treatment, up to approximately 52 weeks for AIN457 (up to 60 weeks for subjects who did not move to the extension study) and up to 16 weeks for placebo. AEs are any sign or symptom that occurs during the conduct of the trial and safety follow-up.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: +1 (862) 778-8300

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER