Document is current

Article History

Received: 29 July 2025

Accepted: 3 November 2025

First Online: 4 December 2025

Declarations

:

: Alessandro Roggeri and Daniela Paola Roggeri report consulting fees from Vertex Pharmaceuticals Incorporated. Francesca Lucca reports payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events and support for attending meetings and/or travel from Vertex Pharmaceuticals Incorporated. Marco Cipolli reports participation on a Data Safety Monitoring Board or Advisory Board for the International Medical Rare Mutations Advisory Panel, Vertex Pharmaceuticals Incorporated and ITA Medical Rare Mutations Advisory Board, Vertex Pharmaceuticals Incorporated.

: The study was approved by the Ethics Committee for Clinical Trials of the Province of Verona and Rovigo (Comitato etico Territoriale Area Sud-Ovest Veneto) in April 2023, which also served as the internal review board for this work (protocol approval number 4232CESC). The CF center database is fully compliant with Data Protection legislation, and the study adhered to the International Society of Pharmacoepidemiology (ISPE) Guidelines for Good Pharmacoepidemiology Practice, the Helsinki Declaration of 1964 and its later amendments, and any applicable national laws, guidelines and regulations. All patients provided informed consent to include their de-identified data in the study and publication.