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Article History

Received: 19 June 2025

Accepted: 24 July 2025

First Online: 28 August 2025

Acknowledgements

: We thank all investigators, study teams and individuals for participating in the trial.

: Mean data will be shared with bona fide researchers who submit a research proposal approved by an independent review board.

: This study was funded in part by the Associazione “Salute con Stile” (no. 1.2022) (Naples, Italy). The funding source had no role in the design and conduct of the trial; collection, management and analysis of the data; preparation, review and approval of the manuscript; and the decision to submit the manuscript for publication.

: MIM has received honoraria for speaking at meetings from Sanofi and Eli Lilly. KE has received honoraria for speaking at meetings from GSK, Sanofi-Aventis and Eli Lilly. All other authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.

: DG, KE, MIM and GB were responsible for the study concept and design, analysis and interpretation of data, and drafting and critical revision of the manuscript. ML, LS, PC, AP, CP, SA and MC were responsible for study visits and data collection, and reviewed the manuscript for important intellectual content. DG, MIM and NDM were responsible for the statistical analysis. All authors reviewed the manuscript and approved the final version of the manuscript for publication. DG is the guarantor of the work and takes full responsibility for its content.