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Authors
Frasca, Giuseppina https://orcid.org/0009-0004-9583-3036
De Palma, Luisa
Megna, Marisa
Rosso, Ilaria
Cocchini, Lorella
Medina, Gianluca
Righi, Gabriele https://orcid.org/0000-0001-6655-9518
Baroni, Annalisa
Del Popolo, Giulio
Bonaccorsi, Astrid
Savoca, Francesco
Costa, Angela
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Article History
Received: 29 April 2025
Revised: 4 March 2026
Accepted: 17 March 2026
First Online: 20 April 2026
Competing interests
: The authors declare no competing interests.
: The study was approved by the relevant ethics committees: Comitato Etico Indipendente (Protocol n. 0086080 dated October 17, 2019), Comitato Etico Catania 1 (Protocol n. 0030887 dated July 09, 2019). The study was conducted following the principles outlined in the Declaration of Helsinki and the Good Clinical Practices concerning clinical investigations of medical devices for human subjects (ISO 14155 and CPMP/ICH/135/95, ICH-E6).
: All participants provided written informed consent for participation.
