Declarations. Conflict of Interest: Roberta Manti MD has received honorarium and fees for lectures from Novo Nordisk; and has participated in the clinical trials sponsored by Novo Nordisk, Eli Lilly, and Bayer. Salvatore De Cosmo has received honorarium and fees for lectures from Novo Nordisk, Eli Lilly, Boehringer, AstraZeneca, MSD, Sanofi, Daiichi Sankyo, Bayer, Guidotti. Paolo Desenzani has participated in the clinical trials sponsored by Novo Nordisk, Eli Lilly, and Sanofi. Lidia Ferrara has participated in the clinical trials sponsored Novo Nordisk. Memoli has received honorarium and fees for lectures from Novo Nordisk, Ely Lilly, AstraZeneca, Sanofi, Bruno Farmaceutici, Abbott, Roche Diagnostics, Novartis and Boehringer, and has participated in the clinical trials sponsored by Novo Nordisk. Angela Girelli has participated in the clinical trials sponsored by Novo Nordisk, Ely Lilly, and Sanofi Pharma. Giuseppe Memoli has received honorarium and fees for lectures Novo Nordisk, Ely Lilly, AstraZeneca, Sanofi, Bruno Farmaceutici, Abbott, Roche diagnostics, Novartis, and Boehringer; and has participated in the clinical trials sponsored by Novo Nordisk. Alessandro Bisio MD is an employee of Novo Nordisk S.p.a, Rome, Italy. Uffe Christian Braae PhD and Alisa Deinega MD, PhD are employees of Novo Nordisk A/S, Søborg, Denmark. Cesare Berra has received honorarium and fees for lectures from Novo Nordisk, Ely Lilly, AstraZeneca, Mundi pharma and Boehringer; and has participated in the clinical trials sponsored by Novo Nordisk Ely Lilly, Sophar and AstraZeneca. Ethical Approval: The study protocol was approved by the appropriate health authorities according to local guidelines and by an Institutional Review Board/Independent Ethics Committee. The study was conducted following Good Pharmacoepidemiology Practices and Good Pharmacovigilance Practices and in accordance with the Declaration of Helsinki. The Ethics Committees included: CET Lombardia 5, Comitato Etico delle Province di Chieti e Pescara, Comitato Etico Catania 1, Comitato Etico Lazio 2, Comitato Etico (CE) Istituti Clinici Scientifici Maugeri, Comitato Etico Casa Sollievo della Sofferenza, CER Umbria, Comitato Etico Palermo 2, Comitato Etico Interaziendale A.O. “SS. Antonio e Biagio e Cesare Arrigo” di Alessandria, Comitato Etico Indipendente Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari, Comitato Etico Brescia, Comitato Etico Regionale per la Sperimentazione Clinica della Regione Toscana, Comitato Etico Territoriale Interaziendale, Comitato Etico Inter-aziendale Campania Sud, Comitato Etico Campania Nord, Comitato Etico Humanitas, Comitato Etico Azienda Sanitaria Locale Lecce, Comitato Etico per le sperimentazioni cliniche della provincia de Vicenza, Comitato Etico Palermo 1, Comitato Etico di Brescia, Comitato Etico Unico Regionale del Friuli Venezia Giulia, Comitato Etico Campania Centro, Comitato Etico per la Sperimentazione delle Province di Treviso e Belluno. All participants provided written informed consent prior to commencement of any study-related activity. The study is registered with ClinicalTrials.gov (NCT05230615).
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