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Article History

Received: 15 April 2025

Accepted: 22 September 2025

First Online: 24 October 2025

Declarations

:

: The study was performed in accordance with the Declaration of Helsinki and was approved by all responsible institutional review boards (Kantonale Ethikkommission Zürich EK-3/2004, Heidelberg University S-188/2003). Throughout the study duration, EMSCI followed the ethics guidelines of the participating countries and implemented changes and new policies as required (see also ). Patients gave their written informed consent before being included in the EMSCI database. Approval for the secondary analysis of the Sygen data was provided by an institutional ethical standards committee on human experimentation at the University of British Columbia (H16-03143). No further approval for the use of data from the Sygen clinical trial was required (Kantonale Ethikkommission Zürich Req-2024-00913). The original Sygen clinical trial also received ethical approval but was conducted before clinical trials were required to be registered; hence, no clinicaltrial.gov identifier is available. All experiments were performed in accordance with relevant guidelines and regulations. Informed consent to participate was obtained from all participants as part of the original study.

: Not applicable.

: The authors declare no competing interests.