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Article History

Received: 24 October 2022

Accepted: 21 February 2023

First Online: 7 March 2023

Change Date: 14 October 2023

Change Type: Update

Change Details: The CRUE CARE TA funding note has been removed

Declarations

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: According to the rules from the Italian Medicines Agency (available at: ), retrospective studies using administrative databases do not require Ethics Committee protocol approval. Furthermore, according to General Authorization for the Processing of Personal Data for Scientific Research Purposes issued by the Italian Privacy Authority on August 10, 2018 (available at: ) this study was exempt from informed consent. In order to protect privacy, and to guarantee individual records anonymity, after the record-linkage between HCU databases and the data extraction procedure, the individual identification codes were automatically converted into anonymous by the regional IT technicians, so that researchers had access to full anonymized data.

: GC received research support from the European Community (EC), the Italian Medicines Agency (AIFA), and the Italian Ministry of Education, Universities and Research (MIUR). He took part in a variety of projects that were funded by pharmaceutical companies (Novartis, GSK, Roche, AMGEN and BMS). He also received honoraria as a member of the Advisory Board of Roche. No other potential conflicts of interest were declared for the other authors.