Tengelmann, Caroline
Joos, Stefanie
Kaußner, Yvonne
Malzahn, Uwe
Lunden, Laura
Klug, Andreas
Häusler, Karl Georg
Escales, Catharina
Maetzler, Walter
Hügen, Klemens
Zolk, Oliver
Heuschmann, Peter U.
Förster, Christian
Kaduszkiewicz, Hanna
Gágyor, Ildikó
Funding for this research was provided by:
Universitätsklinikum Tübingen
Article History
Received: 6 December 2023
Accepted: 18 December 2023
First Online: 6 January 2024
Declarations
:
: Ethical approval has been obtained by the Independent Ethics Committees of the University Hospital Würzburg (No. 110/22_ff), the University Hospital Tübingen (No 450/2022AMG2), and the University of Kiel (No. B 265/22/RE). Informed written consent is obtained from all patients prior to any trial-related procedure. The trial is conducted according to the principles of Good Clinical Practice (GCP) and the principles of the Declaration of Helsinki.
: Not applicable.
: The authors have no trial specific conflicts of interest to declare. Hevert-Arzneimittel GmbH & Co. KG has been contracted to produce the vitamin B compound and its placebo, the pharmacies of the Charité university hospital and of the University Hospital Hamburg-Eppendorf have provided the prednisolone and its placebo, also, they are responsible for packaging and blinding the trial medication. Neither the company nor the pharmacies have influenced the trial design and will participate neither in the clinical project management nor in the collection, analysis, and interpretation of data.