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Article History

Received: 1 July 2024

Accepted: 31 August 2024

First Online: 7 September 2024

Declarations

:

: This is an observational, retrospective, non-interventional 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 Centres for Pharmacoepidemiology and Pharmacovigilance’s Guide on Methodological Standards in Pharmacoepidemiology. Written informed consent to participate in this study was provided by the participants’ legal guardian/next of kin.

: Ethical approval of the study and access to the database was approved by the Internal Scientific Committee of So.Se.Te. Srl, the legal owner of Pedianet. The corresponding author confirms that he had full access to all the data in the study and was finally responsible for the decision to submit it for publication.

: The authors declare that the research was conducted without commercial or financial relationships that could be construed as potential conflicts of interest. The authors have no conflict of interest to declare. We affirm that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of any organization or company.