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CWD, DZ, and JMD are employees of Harmony Biosciences, LLC. BV is an employee of Rho. YD reports receiving funds for speaking, board engagements, and travel to conferences from Avadel\/Flamel, Bioprojet Pharma, Harmony Biosciences, LLC, Idorsia, Jazz Pharmaceuticals, Takeda, Theranexus, and UCB Pharma. JCS is a co-founder of Bioprojet Pharma.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Both studies (NCT 1067222 and NCT 01800045) were conducted in accordance with the Good Clinical Practice guidelines of the International Council for Harmonisation and the ethical principles of the Declaration of Helsinki. Each study protocol was approved by an institutional review board or independent ethics committee at each study site.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients provided written informed consent before study enrollment.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The datasets generated and\/or analyzed for the current study are not publicly available.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"NFW: data analysis and interpretation, and review and editing of the article; CWD: conceptualization, data analysis and interpretation, and review and editing of the article; DZ: conceptualization, data analysis and interpretation, and review and editing of the article; BV: data analysis, and review and editing of the article; JMD: conceptualization, data analysis and interpretation, and review and editing of the article; YD: data analysis and interpretation, and review and editing of the article; and JCS: conceptualization, data analysis and interpretation, and review and editing of the article. All authors provided input into the drafting of the manuscript, have reviewed and approved the final version, and agree to be accountable for the work presented in the manuscript.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 contributions"}}]}}