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Article History

Accepted: 24 September 2024

First Online: 28 October 2024

Declarations

:

: This study was supported by Vertex Pharmaceuticals Incorporated. Clicon S.r.l. Società Benefit is an independent company. The agreement signed by Clicon S.r.l. Società Benefit and Vertex Pharmaceuticals Incorporated does not create any ownership, joint venture, or any similar relationship between parties. Neither CliCon S.r.l. Società Benefit nor any of their representatives are employees of Vertex Pharmaceuticals Incorporated for any purpose.

: Chuka Udeze, Nanxin Li, and Thi Xuan Mai Patricia Dang are employees of Vertex Pharmaceuticals Incorporated and may hold stock or stock options in the company. Gian Luca Forni reports advisory board participation for Agios, Bristol Myers Squibb, and Vertex. Melania Dovizio, Chiara Veronesi, and Luca Degli Esposti do not have conflicts of interest to disclose.

: This study used data available from Clicon. Restrictions apply to the availability of these data, which were used under a licensing agreement.

: The Declaration of Helsinki is not applicable to this study. The study was conducted in accordance with ethical standards, submitted, and approved by the local ethics committees of the participating healthcare entities as follows: Authorization of the Ethics Committee “BAT (Barletta-Andria-Trani) Comitato etico interprovinciale Area I” (protocol number 68/CE/20, approval date 3 December 2020). Authorization of the Ethics Committee “Berica Comitato Etico per le Sperimentazioni Cliniche (CESC) della Provincia di Vicenza” (protocol number 1627, approval date 28 October 2020). Authorization of the Ethics Committee “Foggia Comitato etico interprovinciale Area I” (protocol number 63/CE/20, approval date 3 December 2020). Authorization of the Ethics Committee “Frosinone Comitato Etico Lazio 2” (protocol number 0179046/2020, approval date 28 October 2020). Authorization of the Ethics Committee “Genova Comitato Etico Regionale Liguria” (protocol number 0179046/2020, approval date 14 June 2021). Authorization of the Ethics Committee “Comitato Etico ASL Lecce” (protocol number 34, approval date 04 July 2019). Authorization of the Ethics Committee “Napoli 3 Comitato Etico Interaziendale Campania Sud” (protocol number 51, approval date 02 September 2020). Authorization of the Ethics Committee “Pedemontana Comitato Etico per le Sperimentazioni Cliniche (CESC) della Provincia di Vicenza” (protocol number 0036999, approval date 28 April 2021). Authorization of the Ethics Committee “Comitato Etico delle Province di Chieti e Pescara” (protocol number 07, approval date 18 March 2021). Authorization of the Ethics Committee “ASREM Azienda Sanitaria Regione Molise” (protocol number 101125, approval date 27 October 2020). Authorization of the Ethics Committee “Roma 4 Comitato Etico Lazio 1” (protocol number 1079/CE Lazio 1, approval date 23 September 2020). Authorization of the Ethics Committee “Roma 5 Comitato Etico Lazio 1” (protocol number 1166/CE Lazio 1, approval date 12 October 2020). Authorization of the Ethics Committee “Roma 6 Comitato Etico Lazio 2” (protocol number 0216084/2020, approval date 15 December 2020). Authorization of the Ethics Committee “Salerno Comitato Etico Inter-aziendale Campania Sud” (protocol number 64, approval date 03 November 2020). Authorization of the Ethics Committee “Serenissima Comitato Etico per la Sperimentazione Clinica della provincia di Venezia e IRCCS S. Camillo” (28/07/2020). Authorization of the Ethics Committee “Comitato Etico per le province di L’Aquila e Teramo” (protocol number 11, approval date 24 March 2021). Authorization of the Ethics Committee “Umbria 2 Comitato Etico Regionale Umbria” (protocol number 19414/20/ON, approval date 16 September 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 April 2021).

: Not applicable.

: Not applicable.

: Not applicable.

: All authors contributed to the study conceptualization, design, and results interpretation. Initial data analysis was performed by Melania Dovizio, Chiara Veronesi, and Luca Degli Esposti in consultation with Chuka Udeze, Nanxin Li, Gian Luca Forni, and Thi Xuan Mai Patricia Dang, and all authors reviewed the results. All authors read and approved the final manuscript.