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Article History

Received: 27 May 2025

Accepted: 19 August 2025

First Online: 31 August 2025

Declarations

:

: The study was approved by the local ethics committee (Fondazione Policlinico Universitario Agostino Gemelli IRCCS, study protocol code GIA-DAP-16–005) and registered at eudract.ema.europa.eu (EudraCT No. 2016–003614-27) and ClinicalTrials.gov (NCT 03313752). Written informed consent was obtained from all participants.

: The corresponding author certifies the accuracy of content, in particular, the names of coauthors and that addresses and affiliations are up to date. The corresponding author certifies that all the co-authors have agreed to all the contents and will notify all the authors when the manuscript is accepted. The corresponding author certifies that all authors have seen and approved the final version of the paper, and all are aware of the submission of the paper. All authors consent to publication.

: The authors declare no competing interests.