Brunner, Lisa-Marie http://orcid.org/0000-0002-7555-1443
Riebel, Marco
Wein, Simon
Koller, Michael
Zeman, Florian
Huppertz, Gunnar
Emmer, Tanja
Eberhardt, Yvonne
Schwarzbach, Jens
Rupprecht, Rainer
Nothdurfter, Caroline
Funding for this research was provided by:
Deutsche Forschungsgemeinschaft (422179811)
Universität Regensburg
Article History
Received: 19 January 2024
Accepted: 16 April 2024
First Online: 22 April 2024
Declarations
:
: The ethics committee of the University of Regensburg has approved the study protocol (current version: #4, July 7, 2023) as well as the documents to obtain patient’s informed consent on February 23, 2022 (approval number 22–2784-111). The study will be performed in accordance with the Declaration of Helsinki and following the ICH guidelines for Good Clinical Practice. The trial has been registered at the Clinical Trials Register (EudraCT number: 2021–006773-38) and the German Register of Clinical Studies (DRKS number: DRKS00031099) and it has been approved by the National Institute for Pharmaceutical Security (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM).All participants must give their written informed consent at the beginning of the trial-related measures.
: Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request.
: LMB, MR, SW, MK, FZ, GH, YE, TE, JS, and CN declare no conflicts of interest. RR has served as a consultant for Biogen and SAGA Therapeutics.