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This study was sponsored by Pfizer Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"FDR has received speaker grants and participated in advisory boards for Angelini, Basilea, Biomereuix, BioTest, Correvio, Gilead Sciences, Hikma, MSD, Nordic Pharma, Sanofi Aventis, Pfizer Inc, and ThermoFisher. AB has received honoraria from Gilead Sciences, Jazz Pharmaceuticals, Merck, and Pfizer Inc; he has been speaker for Gilead Sciences, Merck, Novartis, and Pfizer Inc, and has served on Advisory Boards for Gilead Sciences and Pfizer Inc. JAA, JLY, and MRC are employees and shareholders of Pfizer Inc.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Conduct was in accordance with applicable legal and regulatory requirements, the International Conference on Harmonization Guidelines for Good Clinical Practice, and the Declaration of Helsinki. The Institutional Review Boards or Independent Ethics Committees at each investigational center approved the studies.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All patients provided written informed consent.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Upon request, and subject to certain criteria, conditions, and exceptions (see  for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the US and\/or EU or (2) in programs that have been terminated (i.e. development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. 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