Rohr, Brit Silja
Foerster, Kathrin Isabelle
Blank, Antje
Burhenne, Jürgen
Mahmoudi, Mazyar
Haefeli, Walter Emil
Mikus, Gerd http://orcid.org/0000-0003-1783-133X
Funding for this research was provided by:
Universitätsklinikum Heidelberg
Article History
Accepted: 11 June 2021
First Online: 17 July 2021
Declarations
:
: Open Access funding enabled and organized by Projekt DEAL. This trial was funded by the Department’s internal resources. No medical writing support was used.
: Brit Silja Rohr, Kathrin Isabelle Foerster, Antje Blank, Jürgen Burhenne, Mazyar Mahmoudi, Walter Emil Haefeli and Gerd Mikus declare they have no potential conflicts of interest that might be relevant to the contents of this manuscript.
: All procedures performed in studies involving human participants were in accordance with Good Clinical Practice (ICH-GCP) guidelines and the ethical standards of the current Declaration of Helsinki. All included volunteers gave their written informed consent prior to any study procedures. The trial protocol (EudraCT 2017-004453-16) was approved by the responsible Ethics Committee of the Medical Faculty of Heidelberg University and the competent authority (BfArM, Germany).
: Not applicable.
: The trial was registered at the European Union Drug Regulating Authorities for Clinical Trials (EudraCT No. 2017-004453-16).
: Not applicable.
: Not applicable.
: All authors participated in the drafting, critical revision, and approval of the final version of the manuscript. BSR, WEH and GM designed the study; BSR, AB, MM and GM conducted the study; KIF and JB determined all drug concentrations; BSR, KIF and GM performed the data analysis; and all authors performed the interpretation of the results.