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Article History

Received: 26 August 2025

Accepted: 2 December 2025

First Online: 12 December 2025

Declarations

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: The authors declare that there is no competing interest related to the present manuscript and provide the following disclosures: G.V. has received support for travel expenses, hotel accommodation, and registration to meetings from Baxter. M.C. was an employee of Baxter Italia and he was a PhD student at the University of Florence under the supervision of Prof. Gianluca Villa when the study was underway. M.C. disclosed that these interests have not interfered with the analysis and interpretation of the data and the preparation and publishing of the manuscript. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. The other authors have no conflicts of interest to declare.

: The present study was approved by the local Ethics Committee, “Comitato Etico Area Vasta Centro, Regione Toscana,” Florence, Italy (CEAVC 14334, NCT03807414). Being an observational study, enrolled patients did not receive additional medical, pharmacological, or behavioral interventions other than those administered in routine clinical practice. This research study was conducted in accordance with the principles laid out in the original Declaration of Helsinki and its later amendments. Data were captured in REDCap with early pseudonymization and center‑scoped access controls; servers are hosted in secured university facilities with administrator‑only physical access. Where capacity was lacking, consent was obtained from a guardian or legally authorized surrogate in accordance with Italian Decree 101/2018 implementing GDPR (EU 2016/679); patients regaining capacity could withdraw at any time.

: Informed consent was obtained from all subjects involved in the study.