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The protocol was approved by a central institutional review board (Advarra IRB, Columbia, MD, USA, number 0000080) and by a local institutional review board (Biomedical Research Alliance of New York Institutional Review Board, Lake Success, NY, USA, number 00010793) for one study centre.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approvals and consent to participate"}},{"value":"No applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"BR, FOS, LP, and PJ, and are employees of Broadstreet HEOR, which received funds from Pfizer for this work. FD JC, LA and SS are employed by and own stock\/stock options in Pfizer. JA has received personal compensation for serving as a consultant for Pfizer.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"1"}}