Heger, Patrick
Hackert, Thilo
Diener, Markus K.
Feißt, Manuel
Klose, Christina
Dörr-Harim, Colette
Möhlenbrock, Friedhelm
Büchler, Markus W.
Mihaljevic, André L. http://orcid.org/0000-0003-1902-657X
Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (01KG2129)
Universität Ulm
Article History
Received: 15 March 2023
Accepted: 29 April 2023
First Online: 30 May 2023
Declarations
:
: The TRIANGLE trial is conducted according to the Medical Association’s professional code (Berufsordnung der Bundesärztekammer) §15. To ensure the 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 TRIANGLE 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 IEC of the Medical Faculty of the University of Ulm, 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 SPIRIT guidelines.
: Not applicable—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 participant information materials and informed consent form are available from the corresponding author on request.
: The authors declare that they have no competing interests.