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Ignite Creation Date: 2025-12-25 @ 1:40 AM

Ignite Modification Date: 2026-02-25 @ 8:59 PM

Study NCT ID: NCT01954394

Status: COMPLETED

Last Update Posted: 2018-07-24

First Post: 2013-09-16

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Open Label Study of Long Term Safety Evaluation of Alirocumab

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571059', 'term': 'alirocumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'phone': '800-633-1610', 'title': 'Trial Transparency Team', 'phoneExt': '1#', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.', 'description': "Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).", 'eventGroups': [{'id': 'EG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.', 'otherNumAtRisk': 330, 'deathsNumAtRisk': 330, 'otherNumAffected': 183, 'seriousNumAtRisk': 330, 'deathsNumAffected': 4, 'seriousNumAffected': 68}, {'id': 'EG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.', 'otherNumAtRisk': 655, 'deathsNumAtRisk': 655, 'otherNumAffected': 366, 'seriousNumAtRisk': 655, 'deathsNumAffected': 7, 'seriousNumAffected': 144}, {'id': 'EG002', 'title': 'Alirocumab: All Participants', 'description': '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.', 'otherNumAtRisk': 985, 'deathsNumAtRisk': 985, 'otherNumAffected': 549, 'seriousNumAtRisk': 985, 'deathsNumAffected': 11, 'seriousNumAffected': 212}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 62}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 54}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 60}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 95}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 102}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 49}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 93}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 144}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 87}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 82}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 59}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 49}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 50}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic valve disease mixed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mitral valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Prinzmetal angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hereditary non-polyposis colorectal cancer syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute vestibular syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Optic ischaemic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Corneal decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Open angle glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 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'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypersensitivity vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neurogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Air embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 985, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '655', 'groupId': 'OG001'}, {'value': '985', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '83.9', 'groupId': 'OG000'}, {'value': '87.3', 'groupId': 'OG001'}, {'value': '86.2', 'groupId': 'OG002'}]}]}, {'title': 'Any Serious AE', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}, {'value': '22.0', 'groupId': 'OG001'}, {'value': '21.5', 'groupId': 'OG002'}]}]}, {'title': 'Any AE leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 weeks after last study drug administration (maximum of 176 weeks)', 'description': "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.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose or part of a dose of alirocumab in this study.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '611', 'groupId': 'OG001'}, {'value': '917', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-44.9', 'spread': '25.9', 'groupId': 'OG000'}, {'value': '-43.8', 'spread': '28.7', 'groupId': 'OG001'}, {'value': '-44.2', 'spread': '27.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '621', 'groupId': 'OG001'}, {'value': '926', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-46.9', 'spread': '27.5', 'groupId': 'OG000'}, {'value': '-46.9', 'spread': '29.3', 'groupId': 'OG001'}, {'value': '-46.9', 'spread': '28.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}, {'value': '918', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-45.6', 'spread': '28.0', 'groupId': 'OG000'}, {'value': '-47.5', 'spread': '28.8', 'groupId': 'OG001'}, {'value': '-46.9', 'spread': '28.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '594', 'groupId': 'OG001'}, {'value': '887', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-47.7', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '-47.3', 'spread': '28.4', 'groupId': 'OG001'}, {'value': '-47.4', 'spread': '26.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}, {'value': '711', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-47.4', 'spread': '23.8', 'groupId': 'OG000'}, {'value': '-48.2', 'spread': '28.2', 'groupId': 'OG001'}, {'value': '-47.9', 'spread': '26.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-47.4', 'spread': '24.0', 'groupId': 'OG000'}, {'value': '-46.6', 'spread': '31.1', 'groupId': 'OG001'}, {'value': '-46.8', 'spread': '28.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-46.5', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '-49.6', 'spread': '24.6', 'groupId': 'OG001'}, {'value': '-48.5', 'spread': '25.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-43.6', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '-52.2', 'spread': '20.7', 'groupId': 'OG001'}, {'value': '-48.8', 'spread': '17.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '611', 'groupId': 'OG001'}, {'value': '917', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-66.8', 'spread': '45.6', 'groupId': 'OG000'}, {'value': '-67.1', 'spread': '49.2', 'groupId': 'OG001'}, {'value': '-67.0', 'spread': '48.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '621', 'groupId': 'OG001'}, {'value': '926', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-70.3', 'spread': '49.5', 'groupId': 'OG000'}, {'value': '-72.7', 'spread': '52.4', 'groupId': 'OG001'}, {'value': '-71.9', 'spread': '51.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}, {'value': '918', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-67.8', 'spread': '49.7', 'groupId': 'OG000'}, {'value': '-73.9', 'spread': '54.3', 'groupId': 'OG001'}, {'value': '-71.9', 'spread': '52.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '594', 'groupId': 'OG001'}, {'value': '887', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-71.2', 'spread': '44.5', 'groupId': 'OG000'}, {'value': '-74.9', 'spread': '54.5', 'groupId': 'OG001'}, {'value': '-73.7', 'spread': '51.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}, {'value': '711', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-70.2', 'spread': '45.9', 'groupId': 'OG000'}, {'value': '-75.9', 'spread': '55.0', 'groupId': 'OG001'}, {'value': '-74.0', 'spread': '52.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-72.3', 'spread': '45.6', 'groupId': 'OG000'}, {'value': '-75.2', 'spread': '59.7', 'groupId': 'OG001'}, {'value': '-74.2', 'spread': '55.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-73.1', 'spread': '50.0', 'groupId': 'OG000'}, {'value': '-86.2', 'spread': '57.8', 'groupId': 'OG001'}, {'value': '-81.6', 'spread': '55.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-66.1', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '-99.4', 'spread': '48.3', 'groupId': 'OG001'}, {'value': '-86.1', 'spread': '42.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}, {'value': '611', 'groupId': 'OG001'}, {'value': '917', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.729', 'spread': '1.180', 'groupId': 'OG000'}, {'value': '-1.738', 'spread': '1.273', 'groupId': 'OG001'}, {'value': '-1.735', 'spread': '1.242', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '621', 'groupId': 'OG001'}, {'value': '926', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.821', 'spread': '1.282', 'groupId': 'OG000'}, {'value': '-1.883', 'spread': '1.356', 'groupId': 'OG001'}, {'value': '-1.863', 'spread': '1.332', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}, {'value': '918', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.757', 'spread': '1.286', 'groupId': 'OG000'}, {'value': '-1.914', 'spread': '1.405', 'groupId': 'OG001'}, {'value': '-1.861', 'spread': '1.368', 'groupId': 'OG002'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '594', 'groupId': 'OG001'}, {'value': '887', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.843', 'spread': '1.154', 'groupId': 'OG000'}, {'value': '-1.940', 'spread': '1.411', 'groupId': 'OG001'}, {'value': '-1.908', 'spread': '1.332', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}, {'value': '711', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.818', 'spread': '1.190', 'groupId': 'OG000'}, {'value': '-1.965', 'spread': '1.426', 'groupId': 'OG001'}, {'value': '-1.916', 'spread': '1.353', 'groupId': 'OG002'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.874', 'spread': '1.180', 'groupId': 'OG000'}, {'value': '-1.949', 'spread': '1.546', 'groupId': 'OG001'}, {'value': '-1.923', 'spread': '1.428', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.894', 'spread': '1.294', 'groupId': 'OG000'}, {'value': '-2.232', 'spread': '1.498', 'groupId': 'OG001'}, {'value': '-2.114', 'spread': '1.436', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.712', 'spread': '0.641', 'groupId': 'OG000'}, {'value': '-2.574', 'spread': '1.252', 'groupId': 'OG001'}, {'value': '-2.229', 'spread': '1.098', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}, {'value': '11.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '648', 'groupId': 'OG001'}, {'value': '969', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '71.0', 'groupId': 'OG000'}, {'value': '86.1', 'groupId': 'OG001'}, {'value': '81.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '621', 'groupId': 'OG001'}, {'value': '926', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000'}, {'value': '75.7', 'groupId': 'OG001'}, {'value': '76.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}, {'value': '918', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '77.7', 'groupId': 'OG000'}, {'value': '76.4', 'groupId': 'OG001'}, {'value': '76.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '594', 'groupId': 'OG001'}, {'value': '887', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '82.9', 'groupId': 'OG000'}, {'value': '77.6', 'groupId': 'OG001'}, {'value': '79.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}, {'value': '711', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '79.2', 'groupId': 'OG000'}, {'value': '76.8', 'groupId': 'OG001'}, {'value': '77.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000'}, {'value': '76.7', 'groupId': 'OG001'}, {'value': '77.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000'}, {'value': '74.4', 'groupId': 'OG001'}, {'value': '73.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}, {'value': '80.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '648', 'groupId': 'OG001'}, {'value': '969', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000'}, {'value': '66.4', 'groupId': 'OG001'}, {'value': '60.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '621', 'groupId': 'OG001'}, {'value': '926', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000'}, {'value': '53.1', 'groupId': 'OG001'}, {'value': '53.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}, {'value': '918', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000'}, {'value': '53.5', 'groupId': 'OG001'}, {'value': '52.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '594', 'groupId': 'OG001'}, {'value': '887', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000'}, {'value': '53.2', 'groupId': 'OG001'}, {'value': '54.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}, {'value': '711', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000'}, {'value': '56.4', 'groupId': 'OG001'}, {'value': '55.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52.7', 'groupId': 'OG000'}, {'value': '50.9', 'groupId': 'OG001'}, {'value': '51.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000'}, {'value': '48.1', 'groupId': 'OG001'}, {'value': '47.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '1.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '648', 'groupId': 'OG001'}, {'value': '969', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '49.5', 'groupId': 'OG000'}, {'value': '67.1', 'groupId': 'OG001'}, {'value': '61.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '621', 'groupId': 'OG001'}, {'value': '926', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000'}, {'value': '54.3', 'groupId': 'OG001'}, {'value': '54.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}, {'value': '918', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52.1', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}, {'value': '53.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '594', 'groupId': 'OG001'}, {'value': '887', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '57.3', 'groupId': 'OG000'}, {'value': '54.4', 'groupId': 'OG001'}, {'value': '55.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}, {'value': '711', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000'}, {'value': '57.7', 'groupId': 'OG001'}, {'value': '56.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '352', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000'}, {'value': '53.1', 'groupId': 'OG001'}, {'value': '53.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}, {'value': '48.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '618', 'groupId': 'OG001'}, {'value': '928', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-38.1', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '-37.6', 'spread': '26.6', 'groupId': 'OG001'}, {'value': '-37.8', 'spread': '26.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}, {'value': '935', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-40.6', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '-40.4', 'spread': '27.9', 'groupId': 'OG001'}, {'value': '-40.5', 'spread': '27.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}, {'value': '926', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-39.7', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '-40.6', 'spread': '27.6', 'groupId': 'OG001'}, {'value': '-40.3', 'spread': '26.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '597', 'groupId': 'OG001'}, {'value': '891', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-40.8', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '-40.3', 'spread': '26.5', 'groupId': 'OG001'}, {'value': '-40.5', 'spread': '25.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}, {'value': '721', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-39.9', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '-40.5', 'spread': '26.6', 'groupId': 'OG001'}, {'value': '-40.3', 'spread': '25.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '546', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-41.4', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '-38.4', 'spread': '29.7', 'groupId': 'OG001'}, {'value': '-39.5', 'spread': '27.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-39.8', 'spread': '22.9', 'groupId': 'OG000'}, {'value': '-41.8', 'spread': '24.0', 'groupId': 'OG001'}, {'value': '-41.1', 'spread': '23.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-40.7', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '-47.7', 'spread': '18.8', 'groupId': 'OG001'}, {'value': '-44.9', 'spread': '16.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '618', 'groupId': 'OG001'}, {'value': '928', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-27.9', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '-27.7', 'spread': '20.7', 'groupId': 'OG001'}, {'value': '-27.7', 'spread': '20.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}, {'value': '935', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-30.1', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '-30.2', 'spread': '21.6', 'groupId': 'OG001'}, {'value': '-30.1', 'spread': '21.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}, {'value': '926', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-29.0', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '-30.0', 'spread': '21.6', 'groupId': 'OG001'}, {'value': '-29.7', 'spread': '21.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '597', 'groupId': 'OG001'}, {'value': '891', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-29.9', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '-30.1', 'spread': '20.8', 'groupId': 'OG001'}, {'value': '-30.0', 'spread': '19.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}, {'value': '721', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-28.9', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '-29.9', 'spread': '21.1', 'groupId': 'OG001'}, {'value': '-29.6', 'spread': '20.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '546', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-30.2', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '-28.4', 'spread': '22.8', 'groupId': 'OG001'}, {'value': '-29.0', 'spread': '21.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-29.1', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '-31.3', 'spread': '19.1', 'groupId': 'OG001'}, {'value': '-30.5', 'spread': '18.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-32.3', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '-39.1', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '-36.4', 'spread': '13.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '618', 'groupId': 'OG001'}, {'value': '928', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '17.3', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '17.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}, {'value': '935', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '16.9', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '17.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}, {'value': '926', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '19.2', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '18.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '597', 'groupId': 'OG001'}, {'value': '891', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '19.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}, {'value': '721', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '18.7', 'groupId': 'OG001'}, {'value': '7.2', 'spread': '18.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '546', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '18.7', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '18.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '24.8', 'groupId': 'OG001'}, {'value': '8.8', 'spread': '23.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.6', 'spread': '26.2', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '17.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '618', 'groupId': 'OG001'}, {'value': '927', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '40.5', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '47.0', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '44.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '624', 'groupId': 'OG001'}, {'value': '932', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '39.9', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '45.9', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '44.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}, {'value': '925', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '37.5', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '78.0', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '67.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '596', 'groupId': 'OG001'}, {'value': '889', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '43.3', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '42.9', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '43.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}, {'value': '718', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '53.2', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '55.2', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '54.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '545', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '35.3', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '48.5', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '44.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '38.0', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '49.8', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '45.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-22.1', 'spread': '21.9', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '27.1', 'groupId': 'OG001'}, {'value': '-15.0', 'spread': '24.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '606', 'groupId': 'OG001'}, {'value': '913', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-15.0', 'spread': '158.4', 'groupId': 'OG000'}, {'value': '-26.4', 'spread': '40.2', 'groupId': 'OG001'}, {'value': '-22.6', 'spread': '97.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}, {'value': '713', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-13.9', 'spread': '171.7', 'groupId': 'OG000'}, {'value': '-21.4', 'spread': '132.7', 'groupId': 'OG001'}, {'value': '-18.9', 'spread': '146.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-20.1', 'spread': '46.1', 'groupId': 'OG000'}, {'value': '-33.0', 'spread': '25.0', 'groupId': 'OG001'}, {'value': '-28.5', 'spread': '34.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-30.3', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '-29.2', 'spread': '15.4', 'groupId': 'OG001'}, {'value': '-29.6', 'spread': '15.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parent Baseline, Weeks 48, 96, 144, and 168', 'description': '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.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '607', 'groupId': 'OG001'}, {'value': '915', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-36.9', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '-37.8', 'spread': '23.4', 'groupId': 'OG001'}, {'value': '-37.5', 'spread': '22.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}, {'value': '713', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-36.9', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '-38.0', 'spread': '22.9', 'groupId': 'OG001'}, {'value': '-37.6', 'spread': '22.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-33.9', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '-36.9', 'spread': '21.3', 'groupId': 'OG001'}, {'value': '-35.9', 'spread': '21.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-38.0', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '-43.1', 'spread': '20.7', 'groupId': 'OG001'}, {'value': '-41.1', 'spread': '16.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parent Baseline, Weeks 48, 96, 144, and 168', 'description': '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.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '607', 'groupId': 'OG001'}, {'value': '915', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '17.2', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '16.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}, {'value': '713', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '14.1', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '14.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.2', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '18.7', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '17.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '9.3', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '13.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parent Baseline, Weeks 48, 96, 144, and 168', 'description': '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.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '651', 'groupId': 'OG001'}, {'value': '974', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'OG002', 'title': 'Alirocumab: All Participants', 'description': '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.'}], 'classes': [{'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '607', 'groupId': 'OG001'}, {'value': '915', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.340', 'spread': '0.245', 'groupId': 'OG000'}, {'value': '-0.361', 'spread': '0.304', 'groupId': 'OG001'}, {'value': '-0.354', 'spread': '0.286', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}, {'value': '713', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.340', 'spread': '0.228', 'groupId': 'OG000'}, {'value': '-0.375', 'spread': '0.268', 'groupId': 'OG001'}, {'value': '-0.363', 'spread': '0.256', 'groupId': 'OG002'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.342', 'spread': '0.242', 'groupId': 'OG000'}, {'value': '-0.414', 'spread': '0.433', 'groupId': 'OG001'}, {'value': '-0.389', 'spread': '0.379', 'groupId': 'OG002'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.370', 'spread': '0.161', 'groupId': 'OG000'}, {'value': '-0.498', 'spread': '0.280', 'groupId': 'OG001'}, {'value': '-0.447', 'spread': '0.238', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parent Baseline, Weeks 48, 96, 144, and 168', 'description': '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.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'FG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Enrolled', 'groupId': 'FG000', 'numSubjects': '331'}, {'comment': 'Enrolled', 'groupId': 'FG001', 'numSubjects': '655'}]}, {'type': 'Treated', 'achievements': [{'comment': 'Safety population', 'groupId': 'FG000', 'numSubjects': '330'}, {'comment': 'Safety population', 'groupId': 'FG001', 'numSubjects': '655'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '598'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Enrolled but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Poor compliance to protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Participant Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Related to Study Drug administration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'BG000'}, {'value': '655', 'groupId': 'BG001'}, {'value': '985', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'BG001', 'title': 'Alirocumab to Alirocumab 75 or 150 mg Q2W', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '54.1', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '54.4', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '287', 'groupId': 'BG001'}, {'value': '435', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '368', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '317', 'groupId': 'BG000'}, {'value': '623', 'groupId': 'BG001'}, {'value': '940', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '310', 'groupId': 'BG000'}, {'value': '628', 'groupId': 'BG001'}, {'value': '938', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'White/Black or African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'White/Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'White/American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American/Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Calculated LDL-C in mg/dL', 'classes': [{'categories': [{'measurements': [{'value': '148.8', 'spread': '48.8', 'groupId': 'BG000'}, {'value': '153.5', 'spread': '55.3', 'groupId': 'BG001'}, {'value': '152.0', 'spread': '53.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Calculated LDL-C in mg/dL from Friedewald formula (LDL-C = Total cholesterol - High-density lipoprotein cholesterol - \\[Triglyceride/5\\]). This parameter was evaluated at the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Calculated LDL-C in mmol/L', 'classes': [{'categories': [{'measurements': [{'value': '3.854', 'spread': '1.265', 'groupId': 'BG000'}, {'value': '3.977', 'spread': '1.432', 'groupId': 'BG001'}, {'value': '3.936', 'spread': '1.379', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'This parameter was evaluated at the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All enrolled participants who received at least one dose or part of a dose of alirocumab in this study. Participant who was not treated, was not included in any analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-10', 'size': 1017776, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-29T08:01', 'hasProtocol': True}, {'date': '2016-01-25', 'size': 840544, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-29T08:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 986}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-17'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-29', 'studyFirstSubmitDate': '2013-09-16', 'resultsFirstSubmitDate': '2018-06-29', 'studyFirstSubmitQcDate': '2013-09-26', 'lastUpdatePostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-29', 'studyFirstPostDateStruct': {'date': '2013-10-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced Adverse Events (AEs)', 'timeFrame': 'Up to 10 weeks after last study drug administration (maximum of 176 weeks)', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.'}, {'measure': 'Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.'}, {'measure': 'Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.'}, {'measure': 'Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.'}, {'measure': 'Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.'}, {'measure': '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', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.'}, {'measure': 'Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.'}, {'measure': 'Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.'}, {'measure': 'Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.'}, {'measure': 'Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168', 'timeFrame': 'Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168', 'description': '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.'}, {'measure': 'Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168', 'timeFrame': 'Parent Baseline, Weeks 48, 96, 144, and 168', 'description': '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.'}, {'measure': 'Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168', 'timeFrame': 'Parent Baseline, Weeks 48, 96, 144, and 168', 'description': '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.'}, {'measure': 'Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168', 'timeFrame': 'Parent Baseline, Weeks 48, 96, 144, and 168', 'description': '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.'}, {'measure': 'Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168', 'timeFrame': 'Parent Baseline, Weeks 48, 96, 144, and 168', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '30591415', 'type': 'DERIVED', 'citation': 'Dufour R, Hovingh GK, Guyton JR, Langslet G, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Individualized low-density lipoprotein cholesterol reduction with alirocumab titration strategy in heterozygous familial hypercholesterolemia: Results from an open-label extension of the ODYSSEY LONG TERM trial. J Clin Lipidol. 2019 Jan-Feb;13(1):138-147. doi: 10.1016/j.jacl.2018.11.007. Epub 2018 Nov 30.'}, {'pmid': '30293878', 'type': 'DERIVED', 'citation': 'Farnier M, Hovingh GK, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Guyton JR. Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program. Atherosclerosis. 2018 Nov;278:307-314. doi: 10.1016/j.atherosclerosis.2018.08.036. Epub 2018 Sep 1.'}, {'pmid': '30287210', 'type': 'DERIVED', 'citation': 'Hovingh GK, Guyton JR, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Alirocumab dosing patterns during 40 months of open-label treatment in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2018 Nov-Dec;12(6):1463-1470. doi: 10.1016/j.jacl.2018.08.011. Epub 2018 Aug 30.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831).\n\nSecondary Objectives:\n\n* To evaluate the long-term efficacy of alirocumab on lipid parameters.\n* To evaluate the long-term immunogenicity of alirocumab.', 'detailedDescription': 'The maximum study duration will be 176 weeks per participant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\nParticipants with heFH who had completed one of the four parent studies (EFC12492, R727-CL-1112, EFC12732 and LTS11717).\n\nExclusion criteria:\n\nSignificant protocol deviation in the parent study; Any permanent treatment discontinuation from the parent study.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01954394', 'acronym': 'ODYSSEY OLE', 'briefTitle': 'Open Label Study of Long Term Safety Evaluation of Alirocumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'LTS13463'}, 'secondaryIdInfos': [{'id': '2013-002572-40', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1143-3810', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alirocumab 75 or 150 mg Q2W', 'description': 'Alirocumab 75 mg or 150 mg every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 additional weeks (or until the product was commercially available) in participants who completed the parent studies EFC12492, R727-CL-1112, EFC12732 and LTS11717.', 'interventionNames': ['Drug: Alirocumab', 'Drug: Lipid-Modifying Therapy (LMT)']}], 'interventions': [{'name': 'Alirocumab', 'type': 'DRUG', 'otherNames': ['SAR236553', 'REGN727', 'Praluent'], 'description': 'Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.', 'armGroupLabels': ['Alirocumab 75 or 150 mg Q2W']}, {'name': 'Lipid-Modifying Therapy (LMT)', 'type': 'DRUG', 'description': 'Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.', 'armGroupLabels': ['Alirocumab 75 or 150 mg Q2W']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 840321', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 840341', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '90201', 'city': 'Bell Gardens', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840334', 'geoPoint': {'lat': 33.96529, 'lon': -118.15146}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840319', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840336', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840339', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site Number 840337', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 840306', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Investigational Site Number 840328', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840344', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840353', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33308-4311', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840318', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840327', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33174', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840309', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 840351', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840315', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '60181', 'city': 'Oakbrook Terrace', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site Number 840305', 'geoPoint': {'lat': 41.85003, 'lon': -87.96451}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigational Site Number 840333', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigational Site Number 840329', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'facility': 'Investigational Site Number 840345', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '04005', 'city': 'Biddeford', 'state': 'Maine', 'country': 'United States', 'facility': 'Investigational Site Number 840338', 'geoPoint': {'lat': 43.49258, 'lon': -70.45338}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 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{'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'B71 4HJ', 'city': 'West Bromwich', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 826315', 'geoPoint': {'lat': 52.51868, 'lon': -1.9945}}, {'zip': 'B71 4HJ', 'city': 'West Bromwich', 'country': 'United Kingdom', 'facility': 'Investigational Site Number 826316', 'geoPoint': {'lat': 52.51868, 'lon': -1.9945}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}