Trial Outcomes & Findings for Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy (NCT NCT01288443)

Last Updated: 2015-09-24

Results Overview

Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first study drug injection up to 21 days after last study drug injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward \[LOCF\] method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

183 participants

Primary outcome timeframe

Baseline to Week 12 (LOCF)

Results posted on

2015-09-24

Participant Flow

The study was conducted at 38 centers in the United States of America. Overall, 514 participants were screened between January 2011 and August 2011, 331 of whom were screen failures and screen failures were mainly due to exclusion criteria met.

Randomization was stratified according to atorvastatin dose. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1:1:1 ratio after confirmation of selection criteria. 183 participants were randomized.

Participant milestones

Participant milestones
Measure	Placebo Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 50 mg Q2W Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 100 mg Q2W Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 150 mg Q2W Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 200 mg Q4W Alirocumab 200 mg every 4 weeks (Q4W) and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 300 mg Q4W Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Overall Study STARTED	31	30	31	31	30	30
Overall Study Treated	31	30	31	31	29	30
Overall Study COMPLETED	31	29	30	27	23	25
Overall Study NOT COMPLETED	0	1	1	4	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Alirocumab 50 mg Q2W Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 100 mg Q2W Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 150 mg Q2W Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 200 mg Q4W Alirocumab 200 mg every 4 weeks (Q4W) and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 300 mg Q4W Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Overall Study Adverse Event	0	1	1	3	1
Overall Study Poor compliance to protocol	0	0	0	0	1
Overall Study Participant Moved	0	0	1	2	1
Overall Study Consent withdrawn by Participant	0	0	0	0	1
Overall Study Lost to Follow-up	1	0	0	0	0
Overall Study Study drug auto-injector administration	0	0	0	1	1
Overall Study Other than above	0	0	2	1	0

Baseline Characteristics

Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=31 Participants Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 50 mg Q2W n=30 Participants Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 100 mg Q2W n=31 Participants Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 150 mg Q2W n=31 Participants Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 200 mg Q4W n=30 Participants Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 300 mg Q4W n=30 Participants Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Total n=183 Participants Total of all reporting groups
Age, Continuous	53.3 years STANDARD_DEVIATION 8.5 • n=5 Participants	58.5 years STANDARD_DEVIATION 9.1 • n=7 Participants	58.1 years STANDARD_DEVIATION 9.2 • n=5 Participants	59.9 years STANDARD_DEVIATION 11.1 • n=4 Participants	54.9 years STANDARD_DEVIATION 10.8 • n=21 Participants	55.5 years STANDARD_DEVIATION 10.1 • n=8 Participants	56.7 years STANDARD_DEVIATION 10.0 • n=8 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants	21 Participants n=4 Participants	13 Participants n=21 Participants	16 Participants n=8 Participants	96 Participants n=8 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	13 Participants n=5 Participants	10 Participants n=4 Participants	17 Participants n=21 Participants	14 Participants n=8 Participants	87 Participants n=8 Participants
Low-Density Lipoprotein Cholesterol (LDL-C) in mmol/L	3.4 mmol/L STANDARD_DEVIATION 0.7 • n=5 Participants	3.2 mmol/L STANDARD_DEVIATION 0.7 • n=7 Participants	3.3 mmol/L STANDARD_DEVIATION 0.8 • n=5 Participants	3.2 mmol/L STANDARD_DEVIATION 0.7 • n=4 Participants	3.3 mmol/L STANDARD_DEVIATION 0.5 • n=21 Participants	3.4 mmol/L STANDARD_DEVIATION 0.6 • n=8 Participants	3.3 mmol/L STANDARD_DEVIATION 0.7 • n=8 Participants
LDL-C in mg/dL	130.2 mg/dL STANDARD_DEVIATION 27.3 • n=5 Participants	123.2 mg/dL STANDARD_DEVIATION 27.9 • n=7 Participants	127.0 mg/dL STANDARD_DEVIATION 30.4 • n=5 Participants	124.7 mg/dL STANDARD_DEVIATION 26.9 • n=4 Participants	127.2 mg/dL STANDARD_DEVIATION 19.6 • n=21 Participants	131.6 mg/dL STANDARD_DEVIATION 24.8 • n=8 Participants	127.3 mg/dL STANDARD_DEVIATION 26.2 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12 (LOCF)

Population: Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post baseline on-treatment calculated LDL-C.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 50 mg Q2W n=30 Participants Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 100 mg Q2W n=31 Participants Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 150 mg Q2W n=29 Participants Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 200 mg Q4W n=28 Participants Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 300 mg Q4W n=30 Participants Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis	-5.1 percent change Standard Error 3.1	-39.6 percent change Standard Error 3.2	-64.2 percent change Standard Error 3.1	-72.4 percent change Standard Error 3.2	-43.2 percent change Standard Error 3.3	-47.7 percent change Standard Error 3.2

SECONDARY outcome

Timeframe: Baseline to Week 12 (LOCF)

Population: mITT population.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 50 mg Q2W n=30 Participants Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 100 mg Q2W n=31 Participants Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 150 mg Q2W n=29 Participants Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 200 mg Q4W n=28 Participants Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 300 mg Q4W n=30 Participants Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis	-0.20 mmol/L Standard Error 0.10	-1.37 mmol/L Standard Error 0.10	-2.10 mmol/L Standard Error 0.10	-2.38 mmol/L Standard Error 0.10	-1.46 mmol/L Standard Error 0.11	-1.62 mmol/L Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline to Week 12 (LOCF)

Population: mITT population.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 50 mg Q2W n=30 Participants Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 100 mg Q2W n=31 Participants Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 150 mg Q2W n=29 Participants Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 200 mg Q4W n=28 Participants Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 300 mg Q4W n=30 Participants Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis	-7.6 mg/dL Standard Error 3.9	-53.0 mg/dL Standard Error 4.0	-81.2 mg/dL Standard Error 3.9	-92.0 mg/dL Standard Error 4.0	-56.4 mg/dL Standard Error 4.1	-62.5 mg/dL Standard Error 4.0

SECONDARY outcome

Timeframe: Week 12 (LOCF)

Population: mITT population.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 50 mg Q2W n=30 Participants Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 100 mg Q2W n=31 Participants Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 150 mg Q2W n=29 Participants Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 200 mg Q4W n=28 Participants Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 300 mg Q4W n=30 Participants Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and <70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis LDL-C <100 mg/dL (2.59 mmol/L)	16.1 percentage of participants	93.3 percentage of participants	96.8 percentage of participants	100.0 percentage of participants	89.3 percentage of participants	96.7 percentage of participants
Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and <70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis LDL-C <70 mg/dL (1.81 mmol/L)	3.2 percentage of participants	46.7 percentage of participants	83.9 percentage of participants	100.0 percentage of participants	46.4 percentage of participants	56.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12 (LOCF)

Population: Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for lipid parameters analyzed. Here, n signifies the number of participants analysed for each lipid parameter.

Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 50 mg Q2W n=30 Participants Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 100 mg Q2W n=31 Participants Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 150 mg Q2W n=29 Participants Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 200 mg Q4W n=28 Participants Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 300 mg Q4W n=30 Participants Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Percent Change From Baseline in Total Cholesterol, High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis Total Cholesterol (n= 31, 30, 31, 29, 28, 30)	-1.6 percent change Standard Error 2.3	-23.0 percent change Standard Error 2.3	-39.7 percent change Standard Error 2.3	-45.2 percent change Standard Error 2.3	-28.0 percent change Standard Error 2.4	-29.8 percent change Standard Error 2.3
Percent Change From Baseline in Total Cholesterol, High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis HDL-C (n= 31, 30, 31, 29, 28, 30)	-1.0 percent change Standard Error 2.3	6.7 percent change Standard Error 2.4	4.1 percent change Standard Error 2.3	5.5 percent change Standard Error 2.4	6.3 percent change Standard Error 2.5	8.5 percent change Standard Error 2.4
Percent Change From Baseline in Total Cholesterol, High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis Non-HDL-C (n= 31, 30, 31, 29, 28, 30)	-2.2 percent change Standard Error 2.9	-33.6 percent change Standard Error 2.9	-55.6 percent change Standard Error 2.9	-62.5 percent change Standard Error 3.0	-37.4 percent change Standard Error 3.0	-40.7 percent change Standard Error 2.9
Percent Change From Baseline in Total Cholesterol, High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis Apo-B (n= 30, 30, 30, 29, 27, 30)	2.2 percent change Standard Error 2.9	-27.3 percent change Standard Error 2.9	-48.1 percent change Standard Error 2.9	-56.1 percent change Standard Error 2.9	-28.7 percent change Standard Error 3.1	-33.1 percent change Standard Error 2.9

SECONDARY outcome

Timeframe: Baseline to Week 12 (LOCF)

Population: Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for lipid parameters analyzed. Here, n signifies number of participants analysed for each lipid parameter.

Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range).

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 50 mg Q2W n=30 Participants Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 100 mg Q2W n=31 Participants Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 150 mg Q2W n=29 Participants Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 200 mg Q4W n=28 Participants Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 300 mg Q4W n=30 Participants Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Percent Change From Baseline in Fasting Triglycerides and Lipoprotein(a) at Week 12 - On-Treatment Analysis Fasting Triglycerides (n= 31, 30, 31, 29, 28, 30)	9.7 percent change Interval -15.0 to 30.7	-6.6 percent change Interval -17.7 to 7.1	-5.5 percent change Interval -22.1 to 10.7	-18.9 percent change Interval -31.7 to -6.1	-10.8 percent change Interval -25.4 to 13.3	-8.4 percent change Interval -21.5 to 10.1
Percent Change From Baseline in Fasting Triglycerides and Lipoprotein(a) at Week 12 - On-Treatment Analysis Lipoprotein(a) (n= 30, 30, 30, 29, 27, 30)	0.0 percent change Interval -11.8 to 11.5	-13.3 percent change Interval -33.3 to 0.0	-26.1 percent change Interval -36.7 to -8.0	-28.6 percent change Interval -46.9 to -22.2	-16.7 percent change Interval -33.3 to -6.3	-7.9 percent change Interval -18.8 to 0.0

SECONDARY outcome

Timeframe: Baseline to Week 12 (LOCF)

Population: Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for ApoB/ApoA-1 ratio analyzed.

Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 50 mg Q2W n=30 Participants Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 100 mg Q2W n=30 Participants Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 150 mg Q2W n=29 Participants Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 200 mg Q4W n=27 Participants Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 300 mg Q4W n=30 Participants Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 12 - On-Treatment Analysis	0.05 ratio Standard Error 0.03	-0.23 ratio Standard Error 0.03	-0.35 ratio Standard Error 0.03	-0.42 ratio Standard Error 0.03	-0.23 ratio Standard Error 0.03	-0.29 ratio Standard Error 0.03

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Alirocumab 50 mg Q2W

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Alirocumab 100 mg Q2W

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Alirocumab 150 mg Q2W

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Alirocumab 200 mg Q4W

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Alirocumab 300 mg Q4W

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=31 participants at risk Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 50 mg Q2W n=30 participants at risk Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 100 mg Q2W n=31 participants at risk Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 150 mg Q2W n=31 participants at risk Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 200 mg Q4W n=31 participants at risk Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 300 mg Q4W n=28 participants at risk Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Skin and subcutaneous tissue disorders Leukocytoclastic vasculitis	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.6% 1/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.6% 1/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.

Other adverse events

Other adverse events
Measure	Placebo n=31 participants at risk Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 50 mg Q2W n=30 participants at risk Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 100 mg Q2W n=31 participants at risk Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 150 mg Q2W n=31 participants at risk Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 200 mg Q4W n=31 participants at risk Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.	Alirocumab 300 mg Q4W n=28 participants at risk Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Infections and infestations Sinusitis	9.7% 3/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Infections and infestations Influenza	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.7% 2/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Infections and infestations Nasopharyngitis	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	13.3% 4/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	9.7% 3/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.6% 1/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Infections and infestations Upper respiratory tract infection	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.6% 1/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Infections and infestations Urinary tract infection	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	7.1% 2/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Blood and lymphatic system disorders Anaemia	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	7.1% 2/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Nervous system disorders Headache	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.6% 1/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Cardiac disorders Bundle branch block left	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Respiratory, thoracic and mediastinal disorders Cough	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.7% 2/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Gastrointestinal disorders Diarrhoea	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	7.1% 2/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Gastrointestinal disorders Nausea	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.7% 2/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.6% 1/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	7.1% 2/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.6% 1/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Musculoskeletal and connective tissue disorders Pain in extremity	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	7.1% 2/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
General disorders Injection site erythema	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	9.7% 3/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	9.7% 3/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.6% 1/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
General disorders Injection site pruritus	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	9.7% 3/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
General disorders Fatigue	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
General disorders Injection site swelling	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
General disorders Injection site haematoma	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.7% 2/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
General disorders Injection site rash	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.7% 2/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
General disorders Influenza like illness	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Investigations Blood creatine phosphokinase increased	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.3% 1/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Injury, poisoning and procedural complications Fall	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	3.2% 1/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	7.1% 2/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/30 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	6.5% 2/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/31 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.	0.00% 0/28 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP). AEs that developed/worsened during 'treatment emergent period' (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.

Additional Information

Trial Transparency Team

Sanofi

Email: Contact [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER