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Viscusi reports consulting fees from ESTEVE Pharmaceuticals, Heron Therapeutics, Merck, Orion Pharma, Salix Pharmaceuticals, and Vertex Pharmaceuticals. Richard Langford reports consulting and speaker fees from Avenue Therapeutics, BioQ Pharma, Camurus, Compass, Eli Lilly, Gr\u00fcnenthal GmbH, Gr\u00fcnenthal Ltd, GSK, Heron Therapeutics, Medincell, Mundipharma, Pfizer, and Sintetica. Adelaida Morte, Anna Vaqu\u00e9, Jes\u00fas Cebrecos, Mariano Sust, and Jos\u00e9 Mar\u00eda Gim\u00e9nez-Arnau are employees of ESTEVE Pharmaceuticals. Oscar de Leon-Casasola reports personal fees for advisory board membership from ESTEVE Pharmaceuticals during the conduct of the study, and from ESTEVE Pharmaceuticals, Merck, and Stimgenics Medtronic outside of the submitted work.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"All trials were conducted in compliance with Good Clinical Practice guidelines and the Declaration of Helsinki, and all trials received appropriate local ethics committee approval. All patients provided written informed consent. The ESTEVE-SUSA-301 protocol was approved by an Institutional Review Board, Sterling IRB (Atlanta, GA; IRB ID: 5724). The STARDOM1 study protocol was approved by the local ethics committee for each country and\/or study site. The principal investigator was from Spain, and the Spanish ethics committee was the Comit\u00e9 \u00c9tico de Investigaci\u00f3n Cl\u00ednica con Medicamentos del Hospital Universitario de la Princesa (Madrid), resolution no. 20\/17 of 10 November 2016. The STARDOM2 study protocol was reviewed and approved by local ethics committees and all concerned competent authorities for each country and\/or study site. The principal investigator was from Poland, and the Polish ethics committee was the Bioethics Committee at the Poznan University of Medical Sciences, resolution no. 17\/02 of 5 January 2017.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}