Ethics approval and consent to participate
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 