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Kelly M Chin has served as a Scientific Committee member for Johnson & Johnson; has received research grants \/ support from Johnson & Johnson, Altavant, Acceleron, United Therapeutics, Pfizer, Merck, Gossamer Bio; has received support for travel to meetings from Johnson & Johnson; and has received consultancy fees from Johnson & Johnson, Altavant, Acceleron, United Therapeutics, Gossamer Bio and Merck. Vallerie V McLaughlin served as a Scientific Committee member for Johnson & Johnson; received research grants from Aerovate, Altavant, Gossamer Bio, Johnson & Johnson, Merck, and SoniVie; and received consultant fees from Aerami, Aerovate, Altavant, Bayer, Caremark, Corvista, Gossamer Bio, Johnson & Johnson, L.L.C, Merck and United Therapeutics. Rose Ong is an employee of Actelion Pharmaceuticals Ltd, a Johnson & Johnson Company, holds stock\/stock options in Johnson & Johnson and spouse is an employee of Roche. Gwen MacDonald and Nicolas Martin are employees of Actelion Pharmaceuticals Ltd, a Johnson & Johnson Company and hold stock\/stock options in Johnson & Johnson. Assunta Senatore is an employee of Actelion Pharmaceuticals Ltd, a Johnson & Johnson Company. Richard Channick served as a Scientific Committee member for Johnson & Johnson; served on an advisory board for Johnson & Johnson and Bayer; received research grants \/ support from Johnson & Johnson and United therapeutics; received speaker fees from Johnson & Johnson, and Bayer; received consultancy fees from Johnson & Johnson, Bayer and Third pole.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The OPUS and OrPHeUS studies were conducted according to Good Pharmacoepidemiology Practices and the 2008 Declaration of Helsinki ethical principles. Ethical approval was received from independent ethics committees\/institutional review boards (IRB) of participating centers and overseen by an independent Scientific Committee (see Supplementary Appendix I for a full site list including local ethical review boards and Scientific Committee members); protocols were reviewed by the US FDA. Written informed consent obtained from all patients in OPUS, including for publication of anonymized patient data (informed consent was not required in OrPHeUS as an IRB waiver was obtained). The Informed Consent Form in OPUS included a confidentiality clause that all records and documents pertaining to the participation of patients in the OPUS registry would be held strictly confidential and their names would not be reported in any publications resulting from the OPUS registry. Separate master committees for OPUS and OrPHeUS provided overall ethical approval for the studies: IRB approvals were provided by WIRB and Quorum (now Advarra) (OPUS registry; WIRB approval number 2014\u20100816, Quorum Review File number 29120\/Advarra Pro00035124) and WCG\u2010IRB (OrPHeUS study; IRB numbers 2017\u20108051 and 2017\u20102348).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}