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Hung-Yu Chang, Kian Keong Poh, Karam Kostner, and Pisit Hutayanon report that they have nothing to declare. David Colquhoun reports research funding from Amgen, Pfizer, AstraZeneca, Novartis, Sanofi, Bayer, and Novo Nordisk. Jung-Sun Kim reports receiving proctoring fees from Abbott Vascular. Meejin Cho, Jeff Lange, Kamlanathan Kodiappan, and Saikiran Leekha are employees and stockholders of Amgen Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"Informed consent was required for patient\u2019s participation in the study. Study protocol and informed consent forms were reviewed and approved by the institutional review board\/independent ethics committee (see Supplementary Materials, Supplemental Table\u00a0 for full list by site). Central IRBs were used for sites in Australia and Singapore; local IRBD\/ethics committees were used in all other sites. 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