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The authors, including the Jazz Pharmaceuticals authors, were involved with designing the study, collecting, analyzing, interpreting the data, and writing the manuscript. Although Jazz Pharmaceuticals was involved in the review of the manuscript, the content of this article, the ultimate interpretation, and the decision to submit it for publication in CNS Drugs was made by the authors independently.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"RK Bogan has served on the speakers\u2019 bureau and participated in advisory boards for Jazz Pharmaceuticals. N Foldvary-Schaefer has served on an advisory committee for Jazz Pharmaceuticals and participated in clinical trials supported by Jazz Pharmaceuticals, Suven, and Takeda. R Skowronski and A Chen are full-time employees of Jazz Pharmaceuticals who, in the course of this employment, have received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals, plc. MJ Thorpy has received research\/grant support and consultancy fees from Jazz Pharmaceuticals, Harmony Biosciences, Balance Therapeutics, Axsome Therapeutics, and Avadel Pharmaceuticals.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was approved by institutional review boards or ethics committees at all sites and was performed in accordance with the International Council for Harmonisation Guideline for Good Clinical Practice and the Declaration of Helsinki.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All participants provided written informed consent. ClinicalTrials.gov identifier: NCT03030599 (25 January 2017).","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":"All relevant data are provided within the article and supporting files. Jazz has established a process to review requests from qualified external researchers for data from Jazz-sponsored clinical trials in a responsible manner that includes protecting patient privacy, assurance of data security and integrity, and furthering scientific and medical innovation. Additional details on Jazz Pharmaceuticals data sharing criteria and process for requesting access can be found at: .","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Study design: R Skowronski. Participated in the study: RK Bogan, N Foldvary-Schaefer, R Skowronski, MJ Thorpy. Acquisition, analysis, or interpretation of data: All authors. Drafting of the manuscript: All authors. Critical review and revision of the manuscript: All authors. Statistical analysis: A Chen. Final approval of manuscript: All authors. All authors had full access to the data and take full responsibility for the integrity of the data and the accuracy of the data analysis.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}