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TES and AND report consultancy and lecture activity with Idorsia Pharmaceuticals Ltd, Neurocrine, Epilog, Angelini Pharma and Jazz Pharmaceuticals. GZ is an employee of Clinilabs Drug Development Corporation, a company that has received grants from Idorsia Pharmaceuticals Ltd and reports consultancy activity with Idorsia Pharmaceuticals Ltd. TDM and MM are employees of Idorsia Pharmaceuticals Ltd. DSK was an employee of Idorsia Pharmaceuticals Ltd at the time the research was conducted. Non-financial disclosures: none.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Both the phase II and phase III studies were approved by the appropriate health authority, ethics committee, or institutional review board for each participating site and performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Informed consent was obtained from all individual participants included in the studies.","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 during the current study are available from the corresponding author upon reasonable request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Michael Meinel, Tobias Di Marco and Yves Dauvilliers. The first draft of the manuscript was written by Tobias Di Marco and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript and agree to be accountable for the work.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}