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RKS reports honoraria, consulting, and travel support from Sunesis; and institutional research funding from Agios, Astellas, Bayer, Celator\/Jazz, Incyte, and Sunesis. LCM reports research funding from Jazz; consulting and advisory board participation for Incyte, TG Therapeutics, Novartis, and Celgene; and stock ownership in Pfizer. ER reports speakers bureau participation for Alexion Pharmaceuticals and AstraZeneca; and advisory board participation for Celgene. HSP reports paid consultation for Celator\/Jazz. TC reports employment at ERT. DA, BDL, LDM, and QW report employment at and stock ownership in Celator\/Jazz. KB and ACL were former employees of Jazz, and ACL reports stock ownership in Celator\/Jazz. LFN reports no potential conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was conducted according to the provisions of the Declaration of Helsinki and the International Conference on Harmonisation\u2013Good Clinical Practice. The study protocol was approved by the institutional review board at each study site.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"All patients provided written informed consent before enrollment.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}