Lenard, Alexander
Hermann, Simon A.
Stoll, Felicitas
Burhenne, Juergen
Foerster, Kathrin I.
Mikus, Gerd
Meid, Andreas D.
Haefeli, Walter E.
Blank, Antje http://orcid.org/0000-0001-8743-5194
Funding for this research was provided by:
Daiichi Sankyo Europe
Medizinische Fakultät Heidelberg der Universität Heidelberg
Article History
Accepted: 17 February 2023
First Online: 4 March 2023
Declarations
:
: The study protocol was approved by the competent authority (BfArM, Bonn, Germany, Vorlagen Nr. 4043377) and received a positive vote of the responsible Ethics Committee of the Medical Faculty of Heidelberg University, Germany (AFmo-144/2019), and the trial was registered in the EudraCT database (EudraCT 2018-002490-22). This phase I, investigator-initiated, monocenter trial was conducted in accordance with the Declaration of Helsinki, the principles of Good Clinical Practice, and all pertinent legal requirements at the DIN EN ISO 9001-certified early clinical trial unit KliPS of the Department of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital.
: Written informed consent was obtained from all individual participants included in the study.
: No individual patient data is published in this manuscript.
: Walter E. Haefeli declares to have received grants, travel support, and lecture fees from Daiichi Sankyo not related to this work. All other authors declare they have no financial interests.