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Article History

Received: 14 March 2023

Accepted: 21 March 2023

First Online: 8 April 2023

Competing Interests

: FL and EM provided consultancies in protocol preparation for epidemiological studies and data analyses for Dompé, Angelini, Pfizer, and GSK. IG, AR, AM, PLA and CC provided clinical consultancies for Dompé, Angelini, Pfizer, and GSK. DF has no confict of interest to disclose.

: According to a by-law 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), the present study does not require approval by an Ethics Committee in Italy (Italian Drug Agency note of 3 August 2007). This study followed the principles of the Declaration of Helsinki and compliant with the ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) Guide on Methodological Standards in Pharmacoepidemiology.

: The database is fully anonymized.

: Not applicable.

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