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Article History

Received: 13 January 2025

Accepted: 21 February 2025

First Online: 19 March 2025

Declarations

:

: Maria Ciappetta and Domenico Lucatelli are employees of Angelini Pharma S.p.A, Italy. Valentina Perrone, Chiara Veronesi, Andrea Cinti Luciani, Luca Degli Esposti have no conflicts of interest.

: Approval has been obtained from the following ethics committees of the involved: authorization of the Ethics Committee “BAT (Barletta-Andria-Trani) Comitato etico interprovinciale Area I” (protocol number 68/CE/20, approval date 3/12/2020); authorization of the Ethics Committee “Berica Comitato Etico per le Sperimentazioni Cliniche (CESC) della Provincia di Vicenza” (protocol number 1627, approval date 28/10/2020); authorization of the Ethics Committee of Bergamo (protocol number 330, approval date 6/4/2023); authorization of the Ethics Committee “Brindisi Comitato Indipendente di Etica Medica” (protocol number 48148, approval date 28/05/2021); authorization of the “Regional Ethics Committee Liguria” (protocol number 797/2021, approval date 14/03/2022); authorization of the Ethics Committee “Frosinone Comitato Etico Lazio 2” (protocol number 0179046/2020, approval date 28/10/2020); authorization of the Ethics Committee “Napoli 3 Comitato Etico Interaziendale Campania Sud” (protocol number 51, approval date 02/09/2020); authorization of the Ethics Committee “Comitato Etico Palermo 1” (protocol number 02/2021, approval date 24/02/2021); authorization of the Ethics Committee “Pedemontana Comitato Etico per le Sperimentazioni Cliniche (CESC) della Provincia di Vicenza” (protocol number 0036999, approval date 28/04/2021); authorization of the Ethics Committee “Roma 3 Comitato Etico Lazio 2” (protocol number 0031200/2021, approval date 10/02/2021); authorization of the Ethics Committee “Roma 4 Comitato Etico Lazio 1” (protocol number 1079/CE Lazio 1, approval date 23/09/2020); authorization of the Ethics Committee “Roma 5 Comitato Etico Lazio 1” (protocol number 1166/CE Lazio 1, approval date 12/10/2020); authorization of the Ethics Committee “Roma 6 Comitato Etico Lazio 2” (protocol number 0216084/2020, approval date 16/12/2020); authorization of the Ethics Committee “Serenissima Comitato Etico per la Sperimentazione Clinica della provincia di Venezia Comitato Etico per la Sperimentazione Clinica della provincia di Venezia (protocol number 05.08, approval date 08/10/2020); authorization of the Ethics Committee “Umbria 2 Comitato Etico Regionale Umbria” (protocol number 19414/20/ON, approval date 16/09/2020); authorization of the Ethics Committee “Vercelli Comitato Etico Interaziendale A.O. SS. Antonio e Biagio e Cesare Arrigo – Alessandria” (protocol number 0008668, approval date 20/04/2021).