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Methodology and data collection: NW, EGH, JMR, MP, YF and YB. Pharmacokinetic analysis and interpretation: RJ and PJR. Data acquisition and statistical analysis: JSP, RJ, PJR and B\u0141. Writing MW, JSP, PJR, RJ and MM. Review and editing: MW, NW, EGH, JMR, MP, YF, YB, MM, SJ, PJR, RJ, JSP and B\u0141. All authors have read and approved the final version of the manuscript and agree to be accountable for all aspects of the work.","order":1,"name":"Ethics","label":"Authors\u2019 contributions","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"MW is a founder, chief executive officer and majority owner of Celon Pharma S.A. and holds stocks in Celon Pharma S.A. MM, PJR, RJ, B\u0141 and JSP are employees (or were employees during the trial) of Celon Pharma S.A., received a salary and may hold stocks. SJ is a former employee of Celon Pharma S.A., currently employed by Eli Lilly Cork Ltd. and declares stock ownership of Celon Pharma S.A. and Eli Lilly. All other authors declare no competing interests.","order":2,"name":"Ethics","label":"Conflicts of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The trial was conducted in accordance with the Declaration of Helsinki and International Conference on Harmonisation (ICH) Good Clinical Practice guidelines for biomedical research. The protocol and informed consent were approved by the appropriate institutional review boards or independent ethics committees (Supplementary Appendix\n                      \n                      ).","order":3,"name":"Ethics","label":"Ethics approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Participation and any study-related procedures began only after each participant had signed the written informed consent form (ICF).","order":4,"name":"Ethics","label":"Consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":5,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The data that support the findings of this study are available upon reasonable request. 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