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Authors
Krohmer, Evelyn https://orcid.org/0009-0004-8636-7993
Rohr, Brit Silja
Stoll, Felicitas
Gümüs, Katja S.
Bergamino, Mariano
Mikus, Gerd https://orcid.org/0000-0003-1783-133X
Sauter, Max
Burhenne, Jürgen https://orcid.org/0000-0002-2190-1698
Weiss, Johanna
Meid, Andreas D. https://orcid.org/0000-0003-3537-3205
Czock, David https://orcid.org/0000-0003-1217-5134
Blank, Antje https://orcid.org/0000-0001-8743-5194
Haefeli, Walter E. https://orcid.org/0000-0003-0672-6876
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Funding
Funding for this research was provided by:
Universitätsklinikum Heidelberg
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Article History
Accepted: 4 December 2023
First Online: 19 December 2023
Declarations
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: The study protocol was approved by the competent authority (BfArM, Bonn, Germany), received a positive vote of the responsible Ethics Committee of the Medical Faculty of Heidelberg University, Germany (AFmo-956/2021), and the trial was registered in the EudraCT database (EudraCT 2021–006634-39). This single-center, open-label, two-arm, phase I DDI trial was carried out in accordance with GCP, the pertinent version of the Declaration of Helsinki, and all legal requirements at the early clinical trial unit (KliPS) of the Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University, which is certified according to DIN EN ISO 9001:2015.
: Written informed consent was obtained from all participants included in the study before any trial-related procedure.
: Only pseudonymized participant data is published in this manuscript.
: The authors declare no competing interests.
