Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of the Medical University of Vienna (2020-10-04, Austria) and the Ethics Committee “CPP Sud-Ouest et Outre-Mer II” (2021-10-13, France).

Consent to participate

Signed informed consent was obtained from all individual participants included in the study.

Consent to publish

The authors affirm that human research participants provided informed consent for publication of the images.

Trial registration

Study protocol “EPIFLUX” EUDRACT 2019-003137-42 registered 2020-02-28 (Austria), and EUDRACT 2020-00594-78 registered 2021-08-04 (France).

https://www.clinicaltrialsregister.eu/ctr-search/search?query=EPIFLUX

Enrollment of the first participant: 2021-07-13 (Austria) and 2021-12-06 (France).

Competing interests

The authors have no relevant financial or non-financial interests to disclose.