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Authors
Klotz, Rosa
Diener, Markus K.
Schmidt, Thomas
Hackert, Thilo
Graf, Sandra
Fuchs, Hans F.
Grimminger, Peter
Egberts, Jan-Hendrick
Gockel, Ines
van der Sluis, Pieter C.
Doerr-Harim, Colette
Klose, Christina
Feißt, Manuel
Mihaljevic, Andre L. https://orcid.org/0000-0003-1902-657X
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Funding
Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (01KG2028)
Universität Ulm
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Article History
Received: 30 November 2022
Accepted: 4 February 2023
First Online: 10 March 2023
Declarations
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: The MICkey trial is conducted according to the Medical Association’s professional code (Berufsordnung der Bundesärztekammer) §15. To ensure patient’s rights and safety, the responsible investigator will ensure that the trial will be conducted according to the ethical principles laid out in the Declaration of Helsinki. Before participation in the MICkey trial, written informed consent will be obtained from all study participants. This protocol is designed to ensure that the trial will be conducted and analysed in accordance with ICH-GCP E6. The protocol has already been approved by the independent ethics committee (IEC) of the medical faculty of the University of Ulm (157/22, 05/23/22), and secondary approval of the corresponding ethical bodies of all other participating centres has been or will be obtained. The trial protocol has been formulated in accordance with the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) and SPIRIT guidelines.
: A model consent form is provided on request. No identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results.
: The authors declare that they have no competing interests.
