Heger, Patrick
Feißt, Manuel
Krisam, Johannes
Klose, Christina
Dörr-Harim, Colette
Tenckhoff, Solveig
Büchler, Markus W.
Diener, Markus K.
Mihaljevic, André L. http://orcid.org/0000-0003-1902-657X
Funding for this research was provided by:
Deutsche Forschungsgemeinschaft (410901776)
Article History
Received: 23 August 2019
Accepted: 19 November 2019
First Online: 16 December 2019
Ethics approval and consent to participate
: The HULC 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 [CitationRef removed]. Before participation in the HULC 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 [CitationRef removed]. The protocol has already been approved by the independent ethics committee (IEC) of the medical faculty of the University of Heidelberg, 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 [CitationRef removed, CitationRef removed]. The SPIRIT checklist is provided as Additional file InternalRef removed.
: Not applicable.
: The authors declare that they have no competing interests.