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Article History

Received: 12 June 2022

Accepted: 17 February 2023

First Online: 4 March 2023

Declarations

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: The multicentric RCT is conducted in agreement with the principles of the Declaration of Helsinki and the guidelines of Good Clinical Practice. Written informed consent will be obtained from all participants or their legal guardians before enrolment in the study. On the consent form, participants will be asked if they agree to use of their data should they choose to withdraw from the trial. Participants will also be asked for permission for the research team to share relevant data with people from the Universities taking part in the research or from regulatory authorities, where relevant. This trial does not involve collecting biological specimens for storage. There is no anticipated harm and compensation for trial participation. Therefore, this trial is considered to be a low-risk trial. The local ethics committee of the TU Berlin, Germany, has approved the study protocol (No GR_14_20191217). The trial was registered at the German Register for Clinical Trials (DRKS.de) with registration number DRKS00021423 on 12 July 2021: Online available at:ExternalRef removed.

: The authors declare that they have no competing interests.