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Authors
Barabino, Stefano
Rosa, Andrea
Marini, Sara
Bianchi, Carlo Domenico
Rolando, Maurizio
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Funding
Funding for this research was provided by:
Sildeha Swiss
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Article History
Received: 1 August 2024
Accepted: 15 October 2024
First Online: 19 November 2024
Declarations
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: Stefano Barabino, Andrea Rosa, Sara Marini, Carlo Domenico Bianchi, Maurizio Rolando declare that they have no competing interests.
: The study was approved by the Milan Area 1 Ethics Committee with Resolution no. 5247 of 02/07/2023 and authorized by the General Director with resolution no. 329 of 27/2/2023. The study was registered in the ISRCTN registry for Clinical Studies with no. 13587929. All the participants signed an informed consent form. The study was conducted in accordance with the UNI EN ISO 14155 (Rev. January 2012) guidelines, MEDDEV 2.12/2 (Rev. January 2012) guidelines, and the Declaration of Helsinki.
