Updates are available Correction dated 2024-08-23

Article History

Received: 22 May 2024

Accepted: 16 July 2024

First Online: 26 July 2024

Change Date: 23 August 2024

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1007/s40123-024-01019-5

Declarations

:

: Pasquale Aragona, Giuseppe Giannaccare, Edoardo Dammino, Fabiana D’Esposito, Paola Genovese, Elisa Imelde Postorino, and Caterina Gagliano report no conflicts of interest. Claudine Civiale and Maria Grazia Mazzone work at SIFI S.p.A [Via Ercole Patti 36, 95025, Lavinaio, Aci S. Antonio (CT)—Italy].

: This clinical investigation was conducted in compliance with the latest version of the Declaration of Helsinki (October 2013), ICH-GCP Guidelines, international standard ISO 14155:2020 (‘Clinical Investigation of medical devices for human subjects—Good Clinical Practice’), the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, and MEDDEV 2.12/2 Post-market clinical follow-up studies. The participant’s privacy and personal data were also protected according to Regulation (EU) 2016/679 of 27 April 2016 on the protection of persons regarding the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). This clinical investigation was approved by the institutional review boards of the Interagency Ethics Committee of Messina, University Hospital "G. Martino" (Via Consolare Valeria, 1-98125, Messina, Italy) on February 15 2022 (protocol number 21-22 from January 28 2022), the Ethics Committee Catania 1, University Hospital Policlinic "G. Rodolico - San Marco" (Via S. Sofia, 78-95123, Catania, Italy) on March 21 2022 (protocol number 67/2022/PO of the EC Register of Opinions), and the Ethics Committee of the Calabria Region (Sec. Area Centro, Viale Tommaso Campanella, 115-88100, Catanzaro, Italy) on March 17 2022 (protocol number 62 of March 17 2022).