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Agust\u00ed Sellas has received support from Janssen and Novartis; honoraria for lectures from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Janssen, MSD, Novartis, and UCB; and has received support for attending meetings and\/or travel from AbbVie and Eli Lilly. David C. Gruben and M\u00f3nica Valderrama are employees and stockholders of Pfizer\u00a0Inc. Susana G\u00f3mez was an employee and stockholder of Pfizer\u00a0Inc at the time of the analysis, and at her current institute (Hospital Universitario de Salamanca, Salamanca, Spain) has received grant and\/or research support from Amgen, Bristol Myers Squibb, Galapagos, and Novartis. Cassandra Kinch was an employee and stockholder of Pfizer\u00a0Inc at the time of the analysis, and is a current employee and stockholder of Stream Neuroscience Inc. Gustavo Citera has received grants and\/or research support from AbbVie, Amgen, Eli Lilly, Gema, Genzyme, Novartis, Pfizer Inc, and Sanofi Genzyme; and has acted as a consultant for AbbVie, Amgen, Eli\u00a0Lilly, Gema, Genzyme, Novartis, Pfizer Inc, and Sanofi Genzyme.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"Trials were conducted in accordance with the International Council for Harmonisation Good Clinical Practice guidelines and the Declaration of Helsinki. The trial protocols\/documentation were approved by the institutional review board or independent ethics committee at each site; details of all study sites have been previously published [\n                      \n                      \u2013\n                      \n                      ]. All patients provided written, informed consent.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}