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Authors Colin Burke, Catriona Crossan, Emma Tyas, Matthew Hemstock, and Dawn Lee were employed by Lumanity during the study, and their time for development and completion of the study was supported by Jazz Pharmaceuticals, Inc. Author Sally Bowditch, employed by Jazz Pharmaceuticals, Inc., had the following involvement with the study: study design, interpretation of data, writing of the article, and decision to submit for publication.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"All authors met the ICMJE authorship criteria and had full access to the relevant data. Neither honoraria nor payments were made for authorship. Colin\u00a0Burke and Emma\u00a0Tyas are employees of Lumanity, Inc.; Catriona\u00a0Crossan, Matthew Hemstock, and Dawn Lee were employees of Lumanity, Inc., when the study was conducted and are currently employed by Putnam, Source Health Economics, and the University of Exeter, respectively. Sally\u00a0Bowditch is an employee of Jazz Pharmaceuticals, Inc., and holds stock\/stock options in Jazz Pharmaceuticals, Inc.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"All data generated or analyzed during this study are included in this published article (and its online resource files) with the exception of commercially confidential data.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"The present study was based on clinical trial data GWPCARE6 (NCT02544763). The trial was approved by an institutional review board or ethics committee at each participating site (Australia: Hunter New England Research Office; Netherlands: Medical Ethics Review Committee Erasmus MC; Poland: Komisja Bioetyczna przy Instytucie; Spain: Centro Medico Teknon; UK: North East\u2014Newcastle & North Tyneside 2 Research Ethics Committee; USA: Copernicus Group Independent Review Board and Western Institutional Review Board) and was conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation Tripartite Guideline on Good Clinical Practice.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients or their caregivers provided written informed consent, and patients developmentally mature enough to understand the trial provided assent.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"All patients or their caregivers provided written informed consent, and patients developmentally mature enough to understand the trial provided assent.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The cost-effectiveness model used in the study is available from the corresponding author on reasonable request.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors met the ICMJE authorship criteria and had full access to relevant data. CB, CC, DL, and SB contributed to the conception and design of this study. CB, CC, and DL contributed to the acquisition and analysis, and all authors contributed to the analysis and interpretation of data. CB, CC, and SB drafted the manuscript, and all authors were involved in critical review of the manuscript for important intellectual content. All authors read and gave their final approval of the version to be published and agree to be accountable for all aspects of the work.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}