Lapi, Francesco https://orcid.org/0000-0002-4342-9128
Marconi, Ettore
Medea, Gerardo
Rossi, Alessandro
Cricelli, Iacopo
Zanchè, Andrea
Parretti, Damiano
Cricelli, Claudio
Funding for this research was provided by:
PIAM Farmaceutici
Article History
Received: 21 February 2025
Accepted: 23 July 2025
First Online: 30 September 2025
Compliance with ethical standards
:
: The authors declare the following financial interests/personal. relationships which may be considered as potential competing interests: F.L., E.M. and I.C. provided consultancies in protocol preparation for epidemiological studies and data analyses for PIAM Farmaceutici, Dompè, and Daiichi Sankyo. I.C. is an employee at Genomedics SRL. A.R., G.M., D.P., A.Z, and C.C. provided clinical consultancies for PIAM Farmaceutici, Dompè, and Daiichi Sankyo.
: This study followed the principles of the Declaration of Helsinki and compliant with the EnCePP Guide on Methodological Standards in Pharmacoepidemiology ( ). The study protocol was approved by the Scientific Committee of the Italian College of General Practitioners and Primary Care. Given the retrospective nature of the study and the legislation at the time it was conducted, this study did not require an approval from an Ethics Committee (Italian Drug Agency note of 3 August 2007 and subsequent decree on Clinical Research in Italy: GU n.31, 2023).