Trial Outcomes & Findings for Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents (NCT NCT01377012)

Last Updated: 2017-03-29

Results Overview

ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \[HAQ-DI\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

637 participants

Primary outcome timeframe

Week 24

Results posted on

2017-03-29

Participant Flow

At baseline, participants were randomized to 1 of 3 treatment groups. Placebo non- responders at week 16 were re-randomized to receive AIN457 75mg or AIN457 150mg. Placebo responders at Week16 were re-randomized to receive AIN457 75mg or AIN457 150mg at Week 24.

Participant milestones

Participant milestones
Measure	AIN457 10mg/Kg-75mg Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks up to Week 100, then AIN457 150 mg s.c. starting at week 104	AIN457 10mg/Kg-150mg Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks	Placebo Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
Core Study STARTED	210	213	214
Core Study wk16 Re-randomized to AIN 75mg NR	0	0	56
Core Study wk16 Re-randomized to AIN 150mg NR	0	0	53
Core Study wk 24 Re-randomized to AIN 75 mg Res	0	0	38
Core Study wk 24 Re-randomized to AIN 150 mg Res	0	0	34
Core Study COMPLETED	76	81	80
Core Study NOT COMPLETED	134	132	134
Extension Study, Weeks 104-260 STARTED	57	71	68
Extension Study, Weeks 104-260 COMPLETED	0	0	0
Extension Study, Weeks 104-260 NOT COMPLETED	57	71	68

Reasons for withdrawal

Reasons for withdrawal
Measure	AIN457 10mg/Kg-75mg Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks up to Week 100, then AIN457 150 mg s.c. starting at week 104	AIN457 10mg/Kg-150mg Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks	Placebo Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
Core Study Study terminated by Sponsor	47	54	46
Core Study Technical problems	1	0	0
Core Study Withdrawal by Subject	15	23	18
Core Study Protocol Violation	7	3	2
Core Study Pregnancy	0	0	1
Core Study Physician Decision	5	4	10
Core Study Non-Compliant with study treatment	0	0	1
Core Study No Longer require treatment	0	0	1
Core Study Lost to Follow-up	7	5	4
Core Study Lack of Efficacy	41	28	37
Core Study Death	1	1	1
Core Study Adverse Event	10	14	13
Extension Study, Weeks 104-260 Lack of Efficacy	3	0	0
Extension Study, Weeks 104-260 Study terminated by sponsor	52	69	63
Extension Study, Weeks 104-260 Withdrawal by Subject	1	0	3
Extension Study, Weeks 104-260 Physician Decision	1	0	0
Extension Study, Weeks 104-260 Lost to Follow-up	0	0	1
Extension Study, Weeks 104-260 Adverse Event	0	2	1

Baseline Characteristics

Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AIN457 10mg/Kg-75mg n=210 Participants Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks	AIN457 10mg/Kg-150mg n=213 Participants Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks	Placebo n=214 Participants Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24	Total n=637 Participants Total of all reporting groups
Age, Customized <65 years	177 Particpants n=5 Participants	176 Particpants n=7 Participants	182 Particpants n=5 Participants	535 Particpants n=4 Participants
Age, Customized >=65 years	33 Particpants n=5 Participants	37 Particpants n=7 Participants	32 Particpants n=5 Participants	102 Particpants n=4 Participants
Sex: Female, Male Female	186 Participants n=5 Participants	188 Participants n=7 Participants	182 Participants n=5 Participants	556 Participants n=4 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	25 Participants n=7 Participants	32 Participants n=5 Participants	81 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The Full analysis set (FAS) comprised all patients who were randomized and to whom study treatment had been assigned.

Outcome measures

Outcome measures
Measure	AIN457 10mg/Kg-75mg n=210 Participants Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks	AIN457 10mg/Kg-150mg n=213 Participants Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks	Placebo n=214 Participants Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24	35.2 Percentage of Participants	35.2 Percentage of Participants	19.6 Percentage of Participants

PRIMARY outcome

Timeframe: up to week 260

Population: The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.

The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	AIN457 10mg/Kg-75mg n=171 Participants Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks	AIN457 10mg/Kg-150mg n=188 Participants Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks	Placebo n=71 Participants Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
Core Study: Change From Baseline and Week 24 in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)	-0.35 Score on a scale Standard Error 0.039	-0.35 Score on a scale Standard Error 0.038	-0.24 Score on a scale Standard Error 0.051

SECONDARY outcome

Timeframe: Week 24

Population: Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed.

Separate radiographs of each hand/wrist and each foot were taken at basline and Week 24. The radiographs were assessed using the van der Heijde modified Sharp score. The change in the Van der Heijde modified Sharp score is calculated against the baseline value. The total van der Heide modified Sharp score goes from 0 to 448, the bigger the change, the worse it is for the patient.

Outcome measures

Outcome measures
Measure	AIN457 10mg/Kg-75mg n=60 Participants Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks	AIN457 10mg/Kg-150mg n=67 Participants Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks	Placebo n=83 Participants Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
Core Study: Change From Baseline at Week 24 in Van Der Heijde Total Modified Sharp Score	0.59 Score on a scale Standard Error 0.62	0.83 Score on a scale Standard Error 0.68	1.73 Score on a scale Standard Error 0

SECONDARY outcome

Timeframe: 52 week

Population: The Full analysis set (FAS) comprised all patients who were randomized and to whom study treatment had been assigned. N=The total number of subjects in the treatment groups with evaluation

The major clinical response is defined as continuous six-month period of ACR70 response during the 1 year period. ACR70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 70% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \[HAQ-DI\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR70 response results at week 24 used non-responder imputation.

Outcome measures

Outcome measures
Measure	AIN457 10mg/Kg-75mg n=210 Participants Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks	AIN457 10mg/Kg-150mg n=213 Participants Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks	Placebo n=214 Participants Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
Core Study Percentage of Patients Achieving Major Clinical Response (Continuous Six-month Period of ACR70 Response During the 1 Year Period) at Week 52	2.4 Percentage of Participants	0.9 Percentage of Participants	1.4 Percentage of Participants

SECONDARY outcome

Timeframe: week 260

Population: The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1

The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health. Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to week 260

Population: The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1

Low Disease Activity is defined as DAS28 ≤ 3.2. EULAR good response requires an improvement of \> 1.2 in the DAS28 score with a present score of ≤3.2; EULAR moderate response is defined as an improvement of \>0.6 to ≤1.2 in DAS28 and a present score of ≤5.1; or an improvement of \>1.2 and a present score of \>3.2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to week 260

Population: The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1

ACR/EULAR remission is defined as SDAI ≤ 3.3, where SDAI is a measure of disease activity in RA based on 28 tender and swollen joint counts, CRP, Physician and Patient's Global Assessments of Disease

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, up to week 260

Population: The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1

Short Form Health Survey (SF-36) consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to week 260

Population: The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1

Outcome measures

Outcome data not reported

Adverse Events

Any AIN457 75 mg

Serious events: 33 serious events

Other events: 184 other events

Deaths: 0 deaths

Any AIN457 150 mg

Serious events: 48 serious events

Other events: 225 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 91 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis

Phone: 862-778-8300

Results disclosure agreements

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

Restriction type: OTHER

Serious adverse events
Measure	Any AIN457 75 mg n=301 participants at risk Group contains all patients who received AIN 75mg during core period of the study. Includes : participants who were randomized to receive AIN457 i.v (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 injected every 4 weeks + participants who were re-randomized to switch from placebo to AIN457 75 mg at week 16 or week 24 of core study	Any AIN457 150 mg n=392 participants at risk Group contains all patients from the core and the extension that ever received AIN 150mg. This includes : participants who were randomized to AIN457 150 mg arm to receive AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 injected every 4 weeks + participants who were re-randomized to switch from placebo to AIN457 150 mg at week 16 or week 24 + participants who completed core study in any arm and continued in the extension study to receive AIN457 150 mg as open-label study drug	Placebo n=214 participants at risk Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16 of core. Responders were switched to active treatment in week 24 of core
Blood and lymphatic system disorders Anaemia	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.77% 3/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Infections and infestations Soft tissue infection	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Cardiac disorders Acute myocardial infarction	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Cardiac disorders Atrial fibrillation	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.47% 1/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Cardiac disorders Cardiac failure	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Cardiac disorders Cardiogenic shock	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Cardiac disorders Cardiopulmonary failure	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.47% 1/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Cardiac disorders Coronary artery disease	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Cardiac disorders Myocardial infarction	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.47% 1/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Cardiac disorders Myocardial ischaemia	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Eye disorders Cataract	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Eye disorders Macular degeneration	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Gastrointestinal disorders Abdominal hernia	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Gastrointestinal disorders Abdominal pain	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Gastrointestinal disorders Colitis	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Gastrointestinal disorders Dyspepsia	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Gastrointestinal disorders Gastritis	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Gastrointestinal disorders Ileus	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Gastrointestinal disorders Inguinal hernia	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Gastrointestinal disorders Nausea	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Gastrointestinal disorders Vomiting	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
General disorders Disease progression	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
General disorders Non-cardiac chest pain	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.47% 1/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
General disorders Sudden death	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Hepatobiliary disorders Cholecystitis	0.66% 2/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Hepatobiliary disorders Cholelithiasis	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Infections and infestations Appendicitis	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Infections and infestations Bacteraemia	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.47% 1/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Infections and infestations Bronchitis	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.51% 2/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Infections and infestations Cellulitis	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	1.3% 5/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Infections and infestations Gangrene	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Infections and infestations Gastroenteritis	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Infections and infestations Gastroenteritis bacterial	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Infections and infestations Gastroenteritis norovirus	0.00% 0/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.26% 1/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Infections and infestations Gastroenteritis viral	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.
Infections and infestations Helicobacter gastritis	0.33% 1/301 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/392 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.	0.00% 0/214 Safety data is reported (core + extension). Events of placebo patients post switch to active were counted in active group. The "any AIN457 75 mg" "any AIN457 150 mg" groups have all patients originally randomized to group and all placebo patients re-randomized to group, respectively. The "any AIN457 150 mg" group contains all extension patients.