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Ravis are consultants\/advisors to Ocelot Bio, Inc. Yu Bagger was an employee of Ferring Pharmaceuticals A\/S at the time of the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Data archiving is not mandated, but data will be made available upon a reasonable request to the corresponding author.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"This study was conducted at one site in the USA (New Orleans Center for Clinical Research, Knoxville, TN) between September 2014 and March 2015. The protocol and informed consent forms for this study were reviewed by the institutional review board (Crescent City IRB, New Orleans, LA) and conducted in accordance with the Declaration of Helsinki, Good Clinical Practice, and applicable regulatory requirements.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All participants gave their written informed consent before any study-related procedures.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"Conceptualization: GH; Methodology: GH; Formal analysis: WRR and GH; Investigation: YB; Data curation: YB and GH; Writing\u2014original draft preparation: SB; Writing\u2014review and editing: All authors; Funding acquisition: SB; Supervision: GH and SB; Project administration: SB.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}