Trial Outcomes & Findings for Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis (NCT NCT02404350)

NCT ID: NCT02404350

Last Updated: 2020-04-20

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 based on tender 78-joint count, swollen 76-joint count and at least 20% improvement in 3 of the following 5 measures: participant's assessment of PsA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, participant's self-assessed disability (Health Assessment Questionnaire Disability Index (HAQ-DI) score), and acute phase reactant evaluated as (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR)).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 997 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2020-04-20

Participant Flow

Study was conducted at 173 centers in 28 countries.

996 were randomized and dosed, of which 932 participants completed 24 weeks of treatment. Out of the 64 participants who discontinued the most common reasons were participant/guardian decision (32) and adverse events (16).

Participant milestones

Measure	Secukinumab 150 mg Without Load Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab as 1 milliliter (mL) Pre-Filled Syringe (PFS) and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Placebo Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Overall Study STARTED	222	220	222	332
Overall Study COMPLETED	207	214	216	295
Overall Study NOT COMPLETED	15	6	6	37

Reasons for withdrawal

Measure	Secukinumab 150 mg Without Load Participants were subcutaneously (s.c.) administered with 150 milligrams (mg) of secukinumab as 1 milliliter (mL) Pre-Filled Syringe (PFS) and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Placebo Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Overall Study Adverse Event	2	2	3	9
Overall Study Lack of Efficacy	3	1	0	3
Overall Study Lost to Follow-up	2	0	0	1
Overall Study Physician Decision	1	0	0	2
Overall Study Pregnancy	0	0	0	1
Overall Study Withdrawal by Subject	7	3	3	19
Overall Study Due to Non-compliance with treatment	0	0	0	1
Overall Study Due to Technical problems	0	0	0	1

Baseline Characteristics

Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis

Baseline characteristics by cohort

Measure	Secukinumab 150 mg Without Load n=222 Participants Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load n=220 Participants Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load n=222 Participants Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Placebo n=332 Participants Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.	Total n=996 Participants Total of all reporting groups
Age, Continuous	48.8 years STANDARD_DEVIATION 11.82 • n=5 Participants	48.4 years STANDARD_DEVIATION 12.87 • n=7 Participants	48.9 years STANDARD_DEVIATION 12.80 • n=5 Participants	49.0 years STANDARD_DEVIATION 12.12 • n=4 Participants	48.8 years STANDARD_DEVIATION 12.36 • n=21 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	109 Participants n=7 Participants	114 Participants n=5 Participants	171 Participants n=4 Participants	496 Participants n=21 Participants
Sex: Female, Male Male	120 Participants n=5 Participants	111 Participants n=7 Participants	108 Participants n=5 Participants	161 Participants n=4 Participants	500 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	30 Participants n=7 Participants	31 Participants n=5 Participants	51 Participants n=4 Participants	137 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	180 Participants n=5 Participants	160 Participants n=7 Participants	174 Participants n=5 Participants	251 Participants n=4 Participants	765 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants	30 Participants n=7 Participants	17 Participants n=5 Participants	30 Participants n=4 Participants	94 Participants n=21 Participants
Subjects with psoriasis of hands and feet Yes	133 Participants n=5 Participants	135 Participants n=7 Participants	127 Participants n=5 Participants	174 Participants n=4 Participants	569 Participants n=21 Participants
Subjects with psoriasis of hands and feet No	89 Participants n=5 Participants	85 Participants n=7 Participants	95 Participants n=5 Participants	158 Participants n=4 Participants	427 Participants n=21 Participants
Subjects with psoriasis of nail Yes	153 Participants n=5 Participants	135 Participants n=7 Participants	144 Participants n=5 Participants	231 Participants n=4 Participants	663 Participants n=21 Participants
Subjects with psoriasis of nail No	69 Participants n=5 Participants	85 Participants n=7 Participants	78 Participants n=5 Participants	101 Participants n=4 Participants	333 Participants n=21 Participants
Subjects with psoriasis ≥ 3% of BSA Yes	117 Participants n=5 Participants	125 Participants n=7 Participants	110 Participants n=5 Participants	162 Participants n=4 Participants	514 Participants n=21 Participants
Subjects with psoriasis ≥ 3% of BSA No	105 Participants n=5 Participants	95 Participants n=7 Participants	112 Participants n=5 Participants	170 Participants n=4 Participants	482 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 16

Population: The analysis was performed in Full Analysis Set (FAS) population defined as all randomized participants assigned to study treatment. Following the intent-to-treat principle, participants were analyzed according to treatment assigned at randomization by actual anti-Tumor Necrosis Factor (TNF) status. Missing responses were imputed as non-responders.

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 based on tender 78-joint count, swollen 76-joint count and at least 20% improvement in 3 of the following 5 measures: participant's assessment of PsA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, participant's self-assessed disability (Health Assessment Questionnaire Disability Index (HAQ-DI) score), and acute phase reactant evaluated as (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR)).

Outcome measures

Measure	Secukinumab 150 mg Without Load n=222 Participants Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load n=220 Participants Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load n=222 Participants Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Placebo n=332 Participants Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16	59.5 percentage of participants	55.5 percentage of participants	62.6 percentage of participants	27.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: The analysis was performed in FAS population with a measurement that could be evaluated. Participants in placebo group, rescued at Week 16 were also extrapolated (i.e. treated as missing at Week 24).

PsA modified vdH-mTSS scoring method was used to assess bone erosion & joint space narrowing (JSN) in hands & feet; that included the 2nd through 5th distal interphalangeal (DIP) joints of each hand. Maximum score for erosions was 5 in joints of the hands and 10 in joints of the feet with 0=no erosions, 1=discrete erosion, 2=large erosion not passing the mid-line, and 3=large erosion passing the mid-line. JSN is: 0=normal, 1=asymmetrical or minimal narrowing up to a maximum of 25%, 2 = definite narrowing with loss of up to 50% of the normal space, 3 = definite narrowing with loss of 50-99% of the normal space, and 4 = absence of a joint space. Maximum erosion score is 320 (200 for the hands and 120 for the feet), and the max total JSN score is 208 (160 for the hands and 48 for the feet). Total radiographic score (hands & feet combined) ranges from 0 to 528, where higher scores indicate more articular damage

Outcome measures

Measure	Secukinumab 150 mg Without Load n=222 Participants Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load n=220 Participants Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load n=222 Participants Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Placebo n=332 Participants Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS)) baseline	15.25 Mean Sharp Score Standard Deviation 37.098	13.50 Mean Sharp Score Standard Deviation 25.636	12.90 Mean Sharp Score Standard Deviation 23.781	14.95 Mean Sharp Score Standard Deviation 38.236
Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS)) change	-0.10 Mean Sharp Score Standard Deviation 2.872	0.13 Mean Sharp Score Standard Deviation 1.222	0.02 Mean Sharp Score Standard Deviation 1.336	0.50 Mean Sharp Score Standard Deviation 1.708

SECONDARY outcome

Timeframe: Week 16

Population: Psoriasis subset: The psoriasis subset included all FAS patients who had ≥ 3% of the BSA affected by psoriatic skin involvement at baseline.

The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 75 (PASI75) response.

Outcome measures

Measure	Secukinumab 150 mg Without Load n=117 Participants Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load n=125 Participants Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load n=110 Participants Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Placebo n=162 Participants Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 75 (PASI75) Response	68 Participants	75 Participants	77 Participants	20 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Psoriasis subset: The psoriasis subset included all FAS patients who had ≥ 3% of the BSA affected by psoriatic skin involvement at baseline.

The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 90 (PASI90) response.

Outcome measures

Measure	Secukinumab 150 mg Without Load n=117 Participants Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load n=125 Participants Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load n=110 Participants Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Placebo n=162 Participants Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 90 (PASI90) Response	37 Participants	46 Participants	59 Participants	15 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set (FAS)

ACR 50 Response is a measure based on American College of Rheumatology criteria of at least a 50% improvement in the number of tender and swollen joints, and a 50% improvement in at least 3 of the following: the patient's global assessment of disease status; the patient's assessment of pain; the patient's assessment of function measured using the Stanford Health Assessment Questionnaire the physician's global assessment of disease status; serum C-reactive protein levels.

Outcome measures

Measure	Secukinumab 150 mg Without Load n=222 Participants Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load n=220 Participants Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load n=222 Participants Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Placebo n=332 Participants Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Count and Percentage of Patients Achieving an ACR50 Response	71 Participants	79 Participants	88 Participants	27 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set (FAS)

The change (within treatment) on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen), at Week 16 compared with placebo for the disease activity assessed by the changes in The Health Assessment Questionnaire disability index (HAQ-DI) relative to baseline.

Outcome measures

Measure	Secukinumab 150 mg Without Load n=211 Participants Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load n=210 Participants Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load n=211 Participants Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Placebo n=300 Participants Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Change From Baseline in HAQ-DI© Score	-0.45 scores on a scale Standard Error 0.035	-0.44 scores on a scale Standard Error 0.035	-0.55 scores on a scale Standard Error 0.035	-0.21 scores on a scale Standard Error 0.029

SECONDARY outcome

Timeframe: 16 weeks

Population: Full Analysis Set (FAS)

The improvement on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo for the disease activity assessed by the changes in Disease Activity Score for 28 joints (DAS28-CRP) (utilizing High sensitivity C-Reactive Protein (hsCRP)) relative to baseline.

Scores range from 0 (no difficulty) to 3 (unable to do)

Outcome measures

Measure	Secukinumab 150 mg Without Load n=210 Participants Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load n=208 Participants Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load n=209 Participants Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Placebo n=297 Participants Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing High Sensitivity C-Reactive Protein (hsCRP))	-1.29 scores on a scale Standard Error 0.074	-1.29 scores on a scale Standard Error 0.075	-1.49 scores on a scale Standard Error 0.074	-0.63 scores on a scale Standard Error 0.062

SECONDARY outcome

Timeframe: 16 weeks

Population: Enthesitis subset: The enthesitis subset included all FAS patients who had enthesitis at baseline.

The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with enthesitis in the subset of patients who had enthesitis at baseline

Outcome measures

Measure	Secukinumab 150 mg Without Load n=129 Participants Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load n=141 Participants Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load n=140 Participants Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Placebo n=192 Participants Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Count and Percentage of Patients With Enthesitis in the Subset of Patients Who Had Enthesitis at Baseline	75 Participants	64 Participants	62 Participants	124 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Dactylitis subset: The dactylitis subset included all FAS patients who had dactylitis at baseline.

The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with dactylitis in the subset of patients who have dactylitis at baseline

Outcome measures

Measure	Secukinumab 150 mg Without Load n=103 Participants Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load n=80 Participants Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load n=82 Participants Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Placebo n=124 Participants Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Count and Percentage of Participants With Dactylitis in the Subset of Patients Who Have Dactylitis at Baseline	45 Participants	34 Participants	28 Participants	84 Participants

Adverse Events

Secukinumab 150 mg Without Load

Serious events: 6 serious events

Other events: 95 other events

Deaths: 0 deaths

Secukinumab 150 mg With Load

Serious events: 9 serious events

Other events: 82 other events

Deaths: 0 deaths

Secukinumab 300 mg With Load

Serious events: 7 serious events

Other events: 83 other events

Deaths: 0 deaths

Secukinumab Total

Serious events: 25 serious events

Other events: 275 other events

Deaths: 0 deaths

Placebo

Serious events: 12 serious events

Other events: 127 other events

Deaths: 0 deaths

Serious adverse events

Measure	Secukinumab 150 mg Without Load n=222 participants at risk Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1.0 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load n=220 participants at risk Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1.0 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load n=222 participants at risk Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Secukinumab Total n=822 participants at risk Participants were s.c. administered with secukinumab and secukinumab matching placebo at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Placebo n=332 participants at risk Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Renal and urinary disorders Renal colic	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Cardiac disorders Coronary artery disease	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Cardiac disorders Myocardial infarction	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Gastrointestinal disorders Colitis ulcerative	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Gastrointestinal disorders Crohn's disease	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Gastrointestinal disorders Diverticulum	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
General disorders Non-cardiac chest pain	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Immune system disorders Anaphylactic reaction	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Infections and infestations Cellulitis	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.60% 2/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Infections and infestations Otitis externa	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Infections and infestations Tonsillitis	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Infections and infestations Typhoid fever	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Infections and infestations Viral infection	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Injury, poisoning and procedural complications Concussion	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Injury, poisoning and procedural complications Foreign body	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Injury, poisoning and procedural complications Hip fracture	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Injury, poisoning and procedural complications Ulna fracture	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Investigations Computerised tomogram thorax abnormal	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Nervous system disorders Carotid artery stenosis	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Nervous system disorders Polyneuropathy	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Nervous system disorders Sciatica	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Nervous system disorders Transient ischaemic attack	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Psychiatric disorders Suicidal ideation	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Vascular disorders Circulatory collapse	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.12% 1/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Vascular disorders Deep vein thrombosis	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment

Other adverse events

Measure	Secukinumab 150 mg Without Load n=222 participants at risk Participants were s.c. administered with 150 milligrams (mg) of secukinumab as 1 mL PFS and secukinumab matching placebo (1.0 mL PFS) at baseline. Participants received secukinumab matching placebo (2\*1 mL PFS) at Weeks 1, 2 and 3. From week 4 participants received secukinumab 150 mg (1 mL PFS) and secukinumab matching placebo (1 mL PFS) every four weeks up to 100 weeks.	Secukinumab 150 mg With Load n=220 participants at risk Participants were s.c. administered with 150 mg of secukinumab as 1 mL PFS and secukinumab matching placebo (1.0 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Secukinumab 300 mg With Load n=222 participants at risk Participants were s.c. administered with 300 mg of secukinumab as 2\*1 mL PFS (150 mg dose) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100 weeks.	Secukinumab Total n=822 participants at risk Participants were s.c. administered with secukinumab and secukinumab matching placebo at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 up to 100.	Placebo n=332 participants at risk Participants were s.c. administered with secukinumab matching placebo (2\*1 mL PFS) at baseline, weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. Participants were further randomized to two different treatment sequences in 1:1 ratio at baseline as secukinumab matching placebo till Week 16/24 followed by secukinumab 150 mg every 4 weeks starting at Week 16/24 up to 100 weeks and secukinumab matching placebo till Week 16/24 followed by secukinumab 300 mg every 4 weeks starting at Week 16/24 up to 100 weeks.
Blood and lymphatic system disorders Leukopenia	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.7% 6/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.3% 11/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Gastrointestinal disorders Diarrhoea	3.2% 7/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.8% 4/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	4.1% 9/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.6% 21/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	6.6% 22/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Gastrointestinal disorders Nausea	3.2% 7/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.8% 4/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.4% 3/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.7% 14/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.6% 12/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Gastrointestinal disorders Vomiting	1.4% 3/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.7% 6/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.90% 2/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.5% 12/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.60% 2/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
General disorders Fatigue	1.8% 4/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.8% 4/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.8% 4/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.5% 12/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.4% 8/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Infections and infestations Bronchitis	1.4% 3/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.6% 8/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.5% 12/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.60% 2/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Infections and infestations Influenza	0.90% 2/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.8% 4/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.3% 5/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.5% 12/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.90% 3/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Infections and infestations Oral herpes	1.4% 3/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.3% 5/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.97% 8/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.2% 4/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Infections and infestations Rhinitis	0.90% 2/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.91% 2/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.2% 7/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.3% 11/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.90% 3/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Infections and infestations Upper respiratory tract infection	6.3% 14/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	7.7% 17/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.2% 7/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	4.6% 38/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.3% 11/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Infections and infestations Urinary tract infection	2.7% 6/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.6% 8/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.7% 6/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.4% 20/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.4% 8/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Infections and infestations Viral upper respiratory tract infection	5.9% 13/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	6.8% 15/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	6.3% 14/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	5.4% 44/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	8.7% 29/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Injury, poisoning and procedural complications Contusion	1.4% 3/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.3% 5/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.90% 2/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.2% 10/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Injury, poisoning and procedural complications Fall	2.3% 5/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.45% 1/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.73% 6/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.60% 2/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Metabolism and nutrition disorders Dyslipidaemia	3.6% 8/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.8% 4/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.6% 8/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.8% 23/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.3% 11/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Metabolism and nutrition disorders Hypercholesterolaemia	3.6% 8/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	4.1% 9/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.4% 3/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.4% 20/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.60% 2/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Metabolism and nutrition disorders Hyperlipidaemia	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.3% 5/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.4% 3/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.1% 9/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.60% 2/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 3/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.8% 4/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.8% 4/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.5% 12/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.0% 10/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Musculoskeletal and connective tissue disorders Back pain	3.6% 8/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.8% 4/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.8% 4/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.9% 16/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.6% 12/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	1.4% 3/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.4% 3/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.85% 7/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.1% 7/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Nervous system disorders Headache	3.6% 8/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	4.1% 9/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.3% 5/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.8% 23/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.9% 13/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Psychiatric disorders Anxiety	0.45% 1/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.3% 5/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.00% 0/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.73% 6/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.30% 1/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Respiratory, thoracic and mediastinal disorders Cough	3.2% 7/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	0.91% 2/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.8% 4/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.7% 14/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.8% 6/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.3% 5/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.3% 5/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.3% 5/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.9% 16/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.8% 6/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Skin and subcutaneous tissue disorders Pruritus	0.90% 2/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	5.0% 11/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.4% 3/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.9% 16/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.2% 4/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Skin and subcutaneous tissue disorders Psoriasis	1.4% 3/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.4% 3/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.4% 3/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	1.3% 11/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.6% 12/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment
Vascular disorders Hypertension	4.1% 9/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.3% 5/220 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.6% 8/222 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	2.7% 22/822 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment	3.0% 10/332 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 24 weeks All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 24 weeks An Adverse Event (AE) is any sign or symptom that occurs during the study treatment plus 28 days post treatment

Additional Information

Clinical Disclosure Office

Novartis Pharmaceuticals

Phone: +1 (862) 778-8300

Email: Novartis.email@novartis.com

Results disclosure agreements

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

Restriction type: OTHER