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Osteen, Swapna Immani, Tim L. Tapley, Tim Indersmitten, Nicole W.\u00a0Hurst, Tiffany Healey, Kathleen Aertgeerts, Paul A. Negulescu, Sandra M. Lechner) are employees of Vertex Pharmaceuticals and own stock and\/or options in the company.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Animal studies were conducted in Sprague Dawley (CD\n                      \u00ae\n                      [Crl:CD\n                      \u00ae\n                      (SD)]) rats and cynomolgus monkeys. Animals were sourced from Charles River Laboratories (USA). Each study in animals was approved by the laboratory\u2019s Institutional Animal Care and Use Committee (IACUC). Animal care conformed to applicable national\/international guidelines and the studies were conducted in accordance with Good Laboratory Practice (GLP). The clinical trial protocols were approved by a central institutional review board (Advarra Institutional Review Board, Columbia, MD, USA) and all sites accepted this central approval. The trials were conducted according to the International Council for Harmonization Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. All participants provided written informed consent.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}