Trial Outcomes & Findings for Open Label Study of Long Term Safety Evaluation of Alirocumab (NCT NCT01954394)

NCT ID: NCT01954394

Last Updated: 2018-07-24

Results Overview

Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 986 participants
• Primary outcome timeframe: Up to 10 weeks after last study drug administration (maximum of 176 weeks)
• Results posted on: 2018-07-24

Participant Flow

The study was conducted at 177 centers in 24 countries. Overall, 986 participants who completed study EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831) were enrolled between December 2013 and December 2014.

The Day 1 visit of this study was: the end of treatment visit of the 78-week treatment period for participants who completed EFC12492, R727-CL-1112 and EFC12732; and the end of study visit i.e. 8 weeks after completion of the 78-week treatment period for participants who completed LTS11717.

Participant milestones

Measure	Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab 75 mg or 150 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values.	Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
Overall Study STARTED	331	655
Overall Study Treated	330	655
Overall Study COMPLETED	301	598
Overall Study NOT COMPLETED	30	57

Reasons for withdrawal

Measure	Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab 75 mg or 150 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values.	Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
Overall Study Enrolled but not treated	1	0
Overall Study Adverse Event	10	23
Overall Study Poor compliance to protocol	7	7
Overall Study Participant Moved	0	4
Overall Study Related to Study Drug administration	2	2
Overall Study Other than specified above	10	21

Baseline Characteristics

Open Label Study of Long Term Safety Evaluation of Alirocumab

Baseline characteristics by cohort

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=330 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=655 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Total n=985 Participants Total of all reporting groups
Age, Continuous	54.8 years STANDARD_DEVIATION 11.4 • n=5 Participants	54.1 years STANDARD_DEVIATION 12.1 • n=7 Participants	54.4 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	148 Participants n=5 Participants	287 Participants n=7 Participants	435 Participants n=5 Participants
Sex: Female, Male Male	182 Participants n=5 Participants	368 Participants n=7 Participants	550 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	27 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	317 Participants n=5 Participants	623 Participants n=7 Participants	940 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized White	310 Participants n=5 Participants	628 Participants n=7 Participants	938 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized White/Black or African American	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized White/Asian	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized White/American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American/Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Calculated LDL-C in mg/dL	148.8 mg/dL STANDARD_DEVIATION 48.8 • n=5 Participants	153.5 mg/dL STANDARD_DEVIATION 55.3 • n=7 Participants	152.0 mg/dL STANDARD_DEVIATION 53.2 • n=5 Participants
Calculated LDL-C in mmol/L	3.854 mmol/L STANDARD_DEVIATION 1.265 • n=5 Participants	3.977 mmol/L STANDARD_DEVIATION 1.432 • n=7 Participants	3.936 mmol/L STANDARD_DEVIATION 1.379 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 10 weeks after last study drug administration (maximum of 176 weeks)

Population: All enrolled participants who received at least one dose or part of a dose of alirocumab in this study.

Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=330 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=655 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=985 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Percentage of Participants Who Experienced Adverse Events (AEs) Any AE	83.9 percentage of participants	87.3 percentage of participants	86.2 percentage of participants
Percentage of Participants Who Experienced Adverse Events (AEs) Any Serious AE	20.6 percentage of participants	22.0 percentage of participants	21.5 percentage of participants
Percentage of Participants Who Experienced Adverse Events (AEs) Any AE leading to treatment discontinuation	3.0 percentage of participants	3.5 percentage of participants	3.4 percentage of participants

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

Population: Modified ITT (mITT) population: all enrolled and treated participants with 1 baseline (from parent study) and at least 1 post-baseline calculated LDL-C value on-treatment. "Number analyzed" = participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 8	-44.9 percent change Standard Deviation 25.9	-43.8 percent change Standard Deviation 28.7	-44.2 percent change Standard Deviation 27.8
Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 24	-46.9 percent change Standard Deviation 27.5	-46.9 percent change Standard Deviation 29.3	-46.9 percent change Standard Deviation 28.7
Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 48	-45.6 percent change Standard Deviation 28.0	-47.5 percent change Standard Deviation 28.8	-46.9 percent change Standard Deviation 28.6
Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 72	-47.7 percent change Standard Deviation 23.5	-47.3 percent change Standard Deviation 28.4	-47.4 percent change Standard Deviation 26.8
Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 96	-47.4 percent change Standard Deviation 23.8	-48.2 percent change Standard Deviation 28.2	-47.9 percent change Standard Deviation 26.8
Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 120	-47.4 percent change Standard Deviation 24.0	-46.6 percent change Standard Deviation 31.1	-46.8 percent change Standard Deviation 28.8
Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 144	-46.5 percent change Standard Deviation 25.8	-49.6 percent change Standard Deviation 24.6	-48.5 percent change Standard Deviation 25.0
Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 168	-43.6 percent change Standard Deviation 13.4	-52.2 percent change Standard Deviation 20.7	-48.8 percent change Standard Deviation 17.8

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

Population: mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 8	-66.8 mg/dL Standard Deviation 45.6	-67.1 mg/dL Standard Deviation 49.2	-67.0 mg/dL Standard Deviation 48.0
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 24	-70.3 mg/dL Standard Deviation 49.5	-72.7 mg/dL Standard Deviation 52.4	-71.9 mg/dL Standard Deviation 51.4
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 48	-67.8 mg/dL Standard Deviation 49.7	-73.9 mg/dL Standard Deviation 54.3	-71.9 mg/dL Standard Deviation 52.8
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 72	-71.2 mg/dL Standard Deviation 44.5	-74.9 mg/dL Standard Deviation 54.5	-73.7 mg/dL Standard Deviation 51.4
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 96	-70.2 mg/dL Standard Deviation 45.9	-75.9 mg/dL Standard Deviation 55.0	-74.0 mg/dL Standard Deviation 52.2
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 120	-72.3 mg/dL Standard Deviation 45.6	-75.2 mg/dL Standard Deviation 59.7	-74.2 mg/dL Standard Deviation 55.2
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 144	-73.1 mg/dL Standard Deviation 50.0	-86.2 mg/dL Standard Deviation 57.8	-81.6 mg/dL Standard Deviation 55.4
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 168	-66.1 mg/dL Standard Deviation 24.7	-99.4 mg/dL Standard Deviation 48.3	-86.1 mg/dL Standard Deviation 42.4

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

Population: mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 8	-1.729 mmol/L Standard Deviation 1.180	-1.738 mmol/L Standard Deviation 1.273	-1.735 mmol/L Standard Deviation 1.242
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 24	-1.821 mmol/L Standard Deviation 1.282	-1.883 mmol/L Standard Deviation 1.356	-1.863 mmol/L Standard Deviation 1.332
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 48	-1.757 mmol/L Standard Deviation 1.286	-1.914 mmol/L Standard Deviation 1.405	-1.861 mmol/L Standard Deviation 1.368
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 72	-1.843 mmol/L Standard Deviation 1.154	-1.940 mmol/L Standard Deviation 1.411	-1.908 mmol/L Standard Deviation 1.332
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 96	-1.818 mmol/L Standard Deviation 1.190	-1.965 mmol/L Standard Deviation 1.426	-1.916 mmol/L Standard Deviation 1.353
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 120	-1.874 mmol/L Standard Deviation 1.180	-1.949 mmol/L Standard Deviation 1.546	-1.923 mmol/L Standard Deviation 1.428
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 144	-1.894 mmol/L Standard Deviation 1.294	-2.232 mmol/L Standard Deviation 1.498	-2.114 mmol/L Standard Deviation 1.436
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 168	-1.712 mmol/L Standard Deviation 0.641	-2.574 mmol/L Standard Deviation 1.252	-2.229 mmol/L Standard Deviation 1.098

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

Population: mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time Baseline	12.1 percentage of participants	11.5 percentage of participants	11.7 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time Week 8	71.0 percentage of participants	86.1 percentage of participants	81.1 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time Week 24	77.0 percentage of participants	75.7 percentage of participants	76.1 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time Week 48	77.7 percentage of participants	76.4 percentage of participants	76.8 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time Week 72	82.9 percentage of participants	77.6 percentage of participants	79.4 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time Week 96	79.2 percentage of participants	76.8 percentage of participants	77.6 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time Week 120	78.2 percentage of participants	76.7 percentage of participants	77.2 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time Week 144	72.5 percentage of participants	74.4 percentage of participants	73.7 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time Week 168	75.0 percentage of participants	83.3 percentage of participants	80.0 percentage of participants

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

Population: mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time Baseline	0.9 percentage of participants	1.2 percentage of participants	1.1 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time Week 8	47.4 percentage of participants	66.4 percentage of participants	60.1 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time Week 24	53.4 percentage of participants	53.1 percentage of participants	53.2 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time Week 48	51.1 percentage of participants	53.5 percentage of participants	52.7 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time Week 72	57.0 percentage of participants	53.2 percentage of participants	54.5 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time Week 96	53.0 percentage of participants	56.4 percentage of participants	55.3 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time Week 120	52.7 percentage of participants	50.9 percentage of participants	51.5 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time Week 144	46.4 percentage of participants	48.1 percentage of participants	47.5 percentage of participants
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time Week 168	50.0 percentage of participants	33.3 percentage of participants	40.0 percentage of participants

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

Population: mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time Baseline	0.9 percentage of participants	1.2 percentage of participants	1.1 percentage of participants
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time Week 8	49.5 percentage of participants	67.1 percentage of participants	61.3 percentage of participants
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time Week 24	54.1 percentage of participants	54.3 percentage of participants	54.2 percentage of participants
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time Week 48	52.1 percentage of participants	54.5 percentage of participants	53.7 percentage of participants
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time Week 72	57.3 percentage of participants	54.4 percentage of participants	55.4 percentage of participants
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time Week 96	53.0 percentage of participants	57.7 percentage of participants	56.1 percentage of participants
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time Week 120	53.2 percentage of participants	53.1 percentage of participants	53.1 percentage of participants
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time Week 144	46.4 percentage of participants	48.8 percentage of participants	48.0 percentage of participants
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time Week 168	50.0 percentage of participants	33.3 percentage of participants	40.0 percentage of participants

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

Population: mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 8	-38.1 percent change Standard Deviation 24.8	-37.6 percent change Standard Deviation 26.6	-37.8 percent change Standard Deviation 26.0
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 24	-40.6 percent change Standard Deviation 25.5	-40.4 percent change Standard Deviation 27.9	-40.5 percent change Standard Deviation 27.1
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 48	-39.7 percent change Standard Deviation 25.5	-40.6 percent change Standard Deviation 27.6	-40.3 percent change Standard Deviation 26.9
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 72	-40.8 percent change Standard Deviation 22.6	-40.3 percent change Standard Deviation 26.5	-40.5 percent change Standard Deviation 25.3
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 96	-39.9 percent change Standard Deviation 23.5	-40.5 percent change Standard Deviation 26.6	-40.3 percent change Standard Deviation 25.6
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 120	-41.4 percent change Standard Deviation 22.1	-38.4 percent change Standard Deviation 29.7	-39.5 percent change Standard Deviation 27.3
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 144	-39.8 percent change Standard Deviation 22.9	-41.8 percent change Standard Deviation 24.0	-41.1 percent change Standard Deviation 23.6
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 168	-40.7 percent change Standard Deviation 12.3	-47.7 percent change Standard Deviation 18.8	-44.9 percent change Standard Deviation 16.1

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

Population: mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 8	-27.9 percent change Standard Deviation 19.3	-27.7 percent change Standard Deviation 20.7	-27.7 percent change Standard Deviation 20.2
Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 24	-30.1 percent change Standard Deviation 20.3	-30.2 percent change Standard Deviation 21.6	-30.1 percent change Standard Deviation 21.2
Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 48	-29.0 percent change Standard Deviation 20.5	-30.0 percent change Standard Deviation 21.6	-29.7 percent change Standard Deviation 21.2
Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 72	-29.9 percent change Standard Deviation 18.0	-30.1 percent change Standard Deviation 20.8	-30.0 percent change Standard Deviation 19.9
Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 96	-28.9 percent change Standard Deviation 18.3	-29.9 percent change Standard Deviation 21.1	-29.6 percent change Standard Deviation 20.2
Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 120	-30.2 percent change Standard Deviation 17.2	-28.4 percent change Standard Deviation 22.8	-29.0 percent change Standard Deviation 21.0
Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 144	-29.1 percent change Standard Deviation 18.2	-31.3 percent change Standard Deviation 19.1	-30.5 percent change Standard Deviation 18.8
Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 168	-32.3 percent change Standard Deviation 12.4	-39.1 percent change Standard Deviation 14.3	-36.4 percent change Standard Deviation 13.3

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

Population: mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 8	5.6 percent change Standard Deviation 17.1	6.6 percent change Standard Deviation 17.3	6.3 percent change Standard Deviation 17.3
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 24	5.7 percent change Standard Deviation 17.4	5.8 percent change Standard Deviation 16.9	5.8 percent change Standard Deviation 17.1
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 48	7.1 percent change Standard Deviation 17.8	7.2 percent change Standard Deviation 19.2	7.2 percent change Standard Deviation 18.7
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 72	6.7 percent change Standard Deviation 17.6	7.2 percent change Standard Deviation 19.9	7.0 percent change Standard Deviation 19.1
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 96	7.2 percent change Standard Deviation 18.8	7.2 percent change Standard Deviation 18.7	7.2 percent change Standard Deviation 18.7
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 120	8.0 percent change Standard Deviation 18.4	8.1 percent change Standard Deviation 18.7	8.1 percent change Standard Deviation 18.6
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 144	8.8 percent change Standard Deviation 19.2	8.8 percent change Standard Deviation 24.8	8.8 percent change Standard Deviation 23.0
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 168	-6.6 percent change Standard Deviation 26.2	-0.3 percent change Standard Deviation 9.9	-2.8 percent change Standard Deviation 17.1

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

Population: mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 8	3.4 percent change Standard Deviation 40.5	3.5 percent change Standard Deviation 47.0	3.5 percent change Standard Deviation 44.9
Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 24	0.6 percent change Standard Deviation 39.9	1.0 percent change Standard Deviation 45.9	0.9 percent change Standard Deviation 44.0
Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 48	0.8 percent change Standard Deviation 37.5	5.1 percent change Standard Deviation 78.0	3.7 percent change Standard Deviation 67.2
Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 72	4.3 percent change Standard Deviation 43.3	3.6 percent change Standard Deviation 42.9	3.8 percent change Standard Deviation 43.0
Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 96	9.1 percent change Standard Deviation 53.2	9.3 percent change Standard Deviation 55.2	9.2 percent change Standard Deviation 54.5
Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 120	-1.2 percent change Standard Deviation 35.3	10.8 percent change Standard Deviation 48.5	6.7 percent change Standard Deviation 44.8
Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 144	5.0 percent change Standard Deviation 38.0	7.7 percent change Standard Deviation 49.8	6.8 percent change Standard Deviation 45.9
Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 Week 168	-22.1 percent change Standard Deviation 21.9	-10.3 percent change Standard Deviation 27.1	-15.0 percent change Standard Deviation 24.6

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 48, 96, 144, and 168

Population: mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 Week 48	-15.0 percent change Standard Deviation 158.4	-26.4 percent change Standard Deviation 40.2	-22.6 percent change Standard Deviation 97.6
Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 Week 96	-13.9 percent change Standard Deviation 171.7	-21.4 percent change Standard Deviation 132.7	-18.9 percent change Standard Deviation 146.9
Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 Week 144	-20.1 percent change Standard Deviation 46.1	-33.0 percent change Standard Deviation 25.0	-28.5 percent change Standard Deviation 34.3
Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 Week 168	-30.3 percent change Standard Deviation 18.2	-29.2 percent change Standard Deviation 15.4	-29.6 percent change Standard Deviation 15.6

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 48, 96, 144, and 168

Population: mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 Week 48	-36.9 percent change Standard Deviation 21.7	-37.8 percent change Standard Deviation 23.4	-37.5 percent change Standard Deviation 22.9
Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 Week 96	-36.9 percent change Standard Deviation 20.9	-38.0 percent change Standard Deviation 22.9	-37.6 percent change Standard Deviation 22.3
Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 Week 144	-33.9 percent change Standard Deviation 20.9	-36.9 percent change Standard Deviation 21.3	-35.9 percent change Standard Deviation 21.2
Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 Week 168	-38.0 percent change Standard Deviation 9.0	-43.1 percent change Standard Deviation 20.7	-41.1 percent change Standard Deviation 16.5

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 48, 96, 144, and 168

Population: mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 Week 48	5.6 percent change Standard Deviation 14.5	5.8 percent change Standard Deviation 17.2	5.7 percent change Standard Deviation 16.3
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 Week 96	7.8 percent change Standard Deviation 15.4	8.5 percent change Standard Deviation 14.1	8.3 percent change Standard Deviation 14.5
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 Week 144	11.2 percent change Standard Deviation 16.3	10.2 percent change Standard Deviation 18.7	10.6 percent change Standard Deviation 17.8
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 Week 168	0.9 percent change Standard Deviation 19.3	3.9 percent change Standard Deviation 9.3	2.7 percent change Standard Deviation 13.2

SECONDARY outcome

Timeframe: Parent Baseline, Weeks 48, 96, 144, and 168

Population: mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.

Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Outcome measures

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=323 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=651 Participants Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=974 Participants All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 Week 48	-0.340 ratio Standard Deviation 0.245	-0.361 ratio Standard Deviation 0.304	-0.354 ratio Standard Deviation 0.286
Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 Week 96	-0.340 ratio Standard Deviation 0.228	-0.375 ratio Standard Deviation 0.268	-0.363 ratio Standard Deviation 0.256
Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 Week 144	-0.342 ratio Standard Deviation 0.242	-0.414 ratio Standard Deviation 0.433	-0.389 ratio Standard Deviation 0.379
Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 Week 168	-0.370 ratio Standard Deviation 0.161	-0.498 ratio Standard Deviation 0.280	-0.447 ratio Standard Deviation 0.238

Adverse Events

Placebo to Alirocumab 75 or 150 mg Q2W

Serious events: 68 serious events

Other events: 183 other events

Deaths: 4 deaths

Alirocumab to Alirocumab 75 or 150 mg Q2W

Serious events: 144 serious events

Other events: 366 other events

Deaths: 7 deaths

Alirocumab: All Participants

Serious events: 212 serious events

Other events: 549 other events

Deaths: 11 deaths

Serious adverse events

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=330 participants at risk Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=655 participants at risk Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=985 participants at risk All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in this study.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Blood and lymphatic system disorders Anaemia	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Angina pectoris	1.8% 6/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	1.2% 8/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	1.4% 14/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Angina unstable	1.2% 4/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.76% 5/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.91% 9/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Acute myocardial infarction	0.61% 2/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.61% 4/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.61% 6/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Coronary artery disease	0.61% 2/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.61% 4/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.61% 6/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Coronary artery stenosis	0.91% 3/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.46% 3/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.61% 6/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Myocardial infarction	0.61% 2/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.46% 3/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.51% 5/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Atrial fibrillation	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.46% 3/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.41% 4/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Cardiac failure	0.61% 2/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.41% 4/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Cardiac failure congestive	0.91% 3/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.41% 4/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Ventricular tachycardia	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.46% 3/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.41% 4/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Aortic valve stenosis	0.61% 2/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.30% 3/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Supraventricular tachycardia	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Aortic valve disease	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Aortic valve disease mixed	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Arrhythmia	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Atrial flutter	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Bradycardia	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Coronary artery occlusion	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Coronary artery thrombosis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Ischaemic cardiomyopathy	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Mitral valve incompetence	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Mitral valve stenosis	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Pericarditis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Prinzmetal angina	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Cardiac disorders Ventricular dysfunction	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Congenital, familial and genetic disorders Hereditary non-polyposis colorectal cancer syndrome	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Ear and labyrinth disorders Acute vestibular syndrome	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Ear and labyrinth disorders Vertigo positional	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Eye disorders Glaucoma	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Eye disorders Optic ischaemic neuropathy	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Eye disorders Corneal decompensation	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Eye disorders Open angle glaucoma	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Eye disorders Retinal detachment	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Eye disorders Retinal tear	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Eye disorders Retinal vein occlusion	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Hiatus hernia	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Inguinal hernia	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Abdominal hernia	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Abdominal pain	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Barrett's oesophagus	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Colitis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Colitis ischaemic	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Diverticulum intestinal	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Dysphagia	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Gastric polyps	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Gastritis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Gastritis haemorrhagic	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Haematemesis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Haematochezia	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Ileus	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Internal hernia	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Pancreatitis acute	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Pancreatitis chronic	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Rectal ulcer haemorrhage	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Umbilical hernia	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Volvulus	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Gastrointestinal disorders Vomiting	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
General disorders Non-cardiac chest pain	0.61% 2/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.61% 4/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.61% 6/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
General disorders Chest pain	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.30% 3/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
General disorders Death	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
General disorders Malaise	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
General disorders Sudden cardiac death	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
General disorders Vascular stent occlusion	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Hepatobiliary disorders Cholecystitis	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Hepatobiliary disorders Cholelithiasis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Hepatobiliary disorders Hepatic steatosis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Hepatobiliary disorders Hepatocellular injury	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Pneumonia	0.61% 2/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.46% 3/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.51% 5/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Cellulitis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.46% 3/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.30% 3/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Bronchitis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Gastroenteritis	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Hepatitis E	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Catheter site infection	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Clostridium difficile colitis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Corneal abscess	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Cystitis bacterial	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Device related sepsis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Diverticulitis	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Haematoma infection	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Lung infection	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Peritoneal abscess	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Pneumonia pseudomonal	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Postoperative abscess	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Postoperative wound infection	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Pyelonephritis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Stitch abscess	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Viral myocarditis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Muscle rupture	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Alcohol poisoning	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Animal bite	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Cardiac valve replacement complication	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Fall	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Rib fracture	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Tendon rupture	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Thermal burn	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Vascular bypass dysfunction	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Vascular graft thrombosis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Investigations Alanine aminotransferase increased	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Investigations Anticoagulation drug level above therapeutic	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Investigations Aspartate aminotransferase increased	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Investigations Heart rate irregular	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Investigations Transaminases increased	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Investigations Weight decreased	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Metabolism and nutrition disorders Malnutrition	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.61% 2/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.76% 5/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.71% 7/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.76% 5/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.61% 6/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Arthritis	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Acquired claw toe	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Bone pain	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Exostosis	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Fracture pain	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Neck pain	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign pancreatic neoplasm	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma recurrent	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia stage 0	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal papilloma	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lobular breast carcinoma in situ	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphocytic leukaemia	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic glioma	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer stage III	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phyllodes tumour	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland adenoma	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Syncope	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.92% 6/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.71% 7/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Transient ischaemic attack	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.92% 6/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.61% 6/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Amnesia	0.61% 2/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Ischaemic stroke	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Presyncope	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Carotid arteriosclerosis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Cervical radiculopathy	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Dementia	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Embolic cerebral infarction	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Focal dyscognitive seizures	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Headache	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Hemiparesis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Hemiplegia	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Sensory loss	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Toxic encephalopathy	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Nervous system disorders Vascular dementia	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Product Issues Device defective	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Product Issues Device loosening	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Psychiatric disorders Alcoholism	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Psychiatric disorders Anxiety	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Psychiatric disorders Delirium tremens	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Psychiatric disorders Depressed mood	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Psychiatric disorders Major depression	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Psychiatric disorders Suicidal ideation	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Renal and urinary disorders Acute kidney injury	0.61% 2/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.41% 4/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Renal and urinary disorders Nephrolithiasis	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.46% 3/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.41% 4/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Renal and urinary disorders Renal colic	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Renal and urinary disorders Renal failure	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Renal and urinary disorders Renal impairment	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Renal and urinary disorders Renal pain	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Renal and urinary disorders Ureterolithiasis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Renal and urinary disorders Urinary incontinence	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Reproductive system and breast disorders Bartholin's cyst	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Reproductive system and breast disorders Ovarian cyst	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Reproductive system and breast disorders Uterine polyp	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Reproductive system and breast disorders Vaginal dysplasia	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.31% 2/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Respiratory, thoracic and mediastinal disorders Asthma	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Skin and subcutaneous tissue disorders Hypersensitivity vasculitis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Vascular disorders Hypertension	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Vascular disorders Neurogenic shock	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.20% 2/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Vascular disorders Air embolism	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Vascular disorders Aortic aneurysm	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Vascular disorders Aortic dissection	0.30% 1/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.00% 0/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Vascular disorders Iliac artery occlusion	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Vascular disorders Intermittent claudication	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Vascular disorders Malignant hypertension	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Vascular disorders Peripheral artery stenosis	0.00% 0/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.15% 1/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	0.10% 1/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).

Other adverse events

Measure	Placebo to Alirocumab 75 or 150 mg Q2W n=330 participants at risk Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab to Alirocumab 75 or 150 mg Q2W n=655 participants at risk Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.	Alirocumab: All Participants n=985 participants at risk All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in this study.
Gastrointestinal disorders Diarrhoea	5.8% 19/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	6.6% 43/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	6.3% 62/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
General disorders Influenza like illness	3.6% 12/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	6.1% 40/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	5.3% 52/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
General disorders Injection site reaction	7.9% 26/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	4.3% 28/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	5.5% 54/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Bronchitis	5.8% 19/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	6.3% 41/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	6.1% 60/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Influenza	10.3% 34/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	9.3% 61/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	9.6% 95/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Upper respiratory tract infection	9.4% 31/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	10.8% 71/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	10.4% 102/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Urinary tract infection	6.4% 21/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	4.3% 28/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	5.0% 49/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Infections and infestations Viral upper respiratory tract infection	15.5% 51/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	14.2% 93/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	14.6% 144/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Arthralgia	10.3% 34/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	8.1% 53/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	8.8% 87/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Back pain	7.9% 26/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	8.5% 56/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	8.3% 82/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Myalgia	4.5% 15/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	6.7% 44/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	6.0% 59/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Musculoskeletal and connective tissue disorders Pain in extremity	5.5% 18/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	4.7% 31/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	5.0% 49/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
Vascular disorders Hypertension	3.9% 13/330 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	5.6% 37/655 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).	5.1% 50/985 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product. Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).

Additional Information

Trial Transparency Team

Sanofi

Phone: 800-633-1610

Email: Contact-US@sanofi.com

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