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The sponsor was involved with the design and conduct of the study and the collection, management, analysis, and interpretation of the data.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Trial conduct and data analysis were overseen by the executive steering committee (ESM 3) in collaboration with the study sponsors (Bristol-Myers Squibb and Pfizer Ltd). The coordinating center was the ACTION Study Group at Piti\u00e9-Salp\u00eatri\u00e8re hospital. Data were collected, managed, and analyzed by two Clinical Research Organizations: Lincoln (data management, Boulogne-Billancourt, France) and Everest (data analysis, Ontario, Canada). Statistical analyses were validated by an independent statistician from ACTION Academic Research Organization (). The study chairman had unrestricted access to data after database lock. The first author (GM) prepared the first draft of the manuscript, which was revised by all authors, who made the decision to submit the manuscript for publication; they take responsibility for data accuracy.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}},{"value":"GM reports research grants to his institution from ICAN, F\u00e9d\u00e9ration Fran\u00e7aise de Cardiologie, Medtronic, MSD, Pfizer, Sanofi-Aventis, Servier, and INSERM; consultancy fees from Beth Israel Deaconess Medical, Brigham Women\u2019s Hospital, Menarini, TIMI Study Group, and ACTELION; and educational support from Cardiovascular Research Foundation, CME Resources, Europa, Elsevier, Lead-Up, WebMD CCC. CB, AD\u2019A, and HD have received consultancy fees from Bristol-Myers Squibb\/Pfizer. BC reports personal fees from St Jude Medical and research grants from Daiichi Sankyo. HJC and LD report research grants to their institutions from Bristol-Myers Squibb\/Pfizer. FE has received speaker honoraria from Bristol-Myers Squibb. DAL reports research grants to her institution from Bristol-Myers Squibb and Boehringer Ingelheim, and speaker and consultancy fees from Boehringer Ingelheim, Bayer, and Bristol Myers Squibb\/Pfizer. BB is a former employee of Bristol-Myers Squibb. AC is an employee of Pfizer Inc. EV reports grants to his institution from Boehringer and Sanofi; has received consultancy fees from Abbott, Bristol-Myers Squibb, Celgene, Daiichi Sankyo, European Cardiovascular Research Center, Fresenius, LFB, Lilly, Medtronic, Pfizer, and Sorin Group, and has received lecture fees from Novartis.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}}]}}