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Qanatpharma was given the opportunity to review the manuscript for clinical and scientific accuracy, as well as for intellectual property considerations.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Steffen-Sebastian Bolz is an executive board member of Qanatpharma AG and Aphaia\u00a0Pharma AG; Darcy\u00a0Lidington and Alexandra Papaelias are paid consultants for Qanatpharma and Aphaia\u00a0Pharma. Aphaia Pharma had no financial or intellectual involvement in this article.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest\/Competing Interests"}},{"value":"This trial was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonization Good Clinical Practice guidelines, and Canadian regulations. Prior to the start of the trial, the study protocol (#2805; QP586-01) and study documents were reviewed and approved by an independent Institutional Review Board (Optimum Clinical Research Inc.). All participants provided signed and dated written informed consent prior to admission to the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"All participants provided signed and dated written informed consent prior to admission to the study.","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":"To ensure independent interpretation of the clinical study results and to enable the authors to fulfill their role and obligations under the International Committee of Medical Journal Editors criteria, Qanatpharma AG grants all authors access to clinical study data pertinent to the development of the publication. Scientific and medical researchers can request access to clinical study data. Qanatpharma AG will provide access upon request to individual de-identified participant data reported in the publication beginning 12 months after publication and for up to 36 months following article publication. Data sharing requests can be made by qualified researchers for approved proposals under the terms of a Data Use Agreement. Contact information will be provided at the time of article publication.","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":"The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors. All authors approved the final version for submission. 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