Madisch, Ahmed https://orcid.org/0000-0001-9163-5893
Pace, Fabio
Menzel, Daniel
Funk, Petra
Stracke, Berenike
Schön, Christiane
Labenz, Joachim
Funding for this research was provided by:
Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany
Article History
Received: 11 October 2024
Accepted: 14 April 2025
First Online: 7 May 2025
Declarations
:
: AM, FP, DM, CS, and JL have received honoraria from Dr. Willmar Schwabe GmbH & Co. KG. PF and BS are employees of Dr. Willmar Schwabe GmbH & Co. KG.
: The study was conducted with the approval of the Ethical Committee (Landesärztekammer Baden-Württemberg, May 18, 2022; reference no. F-2022-038). It was prospectively registered at the German Clinical Trials Register (DRKS, identifier DRKS00029344) and carried out in accordance with the principles of the Declaration of Helsinki, the Professional Code for Physicians in Baden-Württemberg, and in orientation to the International Organisation for Standardization (ISO) 14155:2020 (Clinical investigation of medical devices for human subjects). Written informed consent was obtained from all individual participants included in the study.