Burchardi, Jennifer Marie
Spyra, Karla
Brünger, Martin
Funding for this research was provided by:
Charité - Universitätsmedizin Berlin
Article History
Received: 9 February 2023
Accepted: 12 April 2023
First Online: 20 April 2023
Declarations
:
: The study is carried out in accordance with the Declaration of Helsinki. The study protocol has been approved by the Ethics Committee of the Charité – Universitätsmedizin Berlin, Berlin, Germany (number: EA4/215/21). No legal or ethical concerns were identified. Informed consent will be obtain from all subjects and/or their legal guardian(s). All participants will receive a written study information about the study objectives, participation, and their right to decline participation. On 03 March 2022, the study was prospectively registered in the German Clinical Trials Register (DRKS00028303, UTN U11111-1275–0063). The World Health Organization Trial Registration Data Set is available as Additional File InternalRef removed. Significant changes are sent to the Ethics Committee for approval before introduction. Modifications will be documented in the German Clinical Trials Register and reported transparently in study reports.
: Not applicable.
: The authors declare that they have no competing interests.