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Article History

Received: 29 March 2025

Accepted: 4 August 2025

First Online: 22 August 2025

Competing interests

: The authors declare no competing interests.

: This is an observational, retrospective, noninterventional study. According to a bylaw on the classification and implementation of observational drug-related research, as issued by the Italian National Drug Agency (an entity belonging to the Italian Ministry of Health), this study does not require approval by an ethics committee in Italy (Italian Drug Agency note on August 3, 2007). This study was conducted in accordance with the tenets of the Declaration of Helsinki and was compliant with the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance’s Guide on Methodological Standards in Pharmacoepidemiology. The Internal Scientific Committee of Società Servizi Telematici Srl, the legal owner of Pedianet approved ethical approval of the study and access to the database.

: This is an observational, retrospective, noninterventional study. According to a bylaw on the classification and implementation of observational drug-related research, as issued by the Italian National Drug Agency (an entity belonging to the Italian Ministry of Health), this study does not require approval by an ethics committee in Italy (Italian Drug Agency note on August 3, 2007). This study was conducted in accordance with the tenets of the Declaration of Helsinki and was compliant with the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance’s Guide on Methodological Standards in Pharmacoepidemiology. The Internal Scientific Committee of Società Servizi Telematici Srl, the legal owner of Pedianet approved the study and access to the database.