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Article History

Received: 19 April 2024

Accepted: 30 August 2024

First Online: 6 September 2024

Declarations

:

: The protocol on which this ambispective observational study was based has been approved by the ethics committee of IRCCS Hospital San Raffaele (number 181/INT/2021). This study was conducted in accordance with all the principles established by the Eighteenth World Medical Assembly (Helsinki, 1964) and all relevant amendments drafted by the World Medical Assemblies and the ICH guidelines for GMP. In addition, the study was conducted in accordance with all international laws and standards and the national laws and regulations of the country in which it was conducted (Italy), as well as the relevant guidelines. The study leader (according to the requirements of the applicable regulations) or a person designated by him/her and under his/her responsibility informed the patient of all relevant aspects of the research protocol. All participants were informed as comprehensively as possible about all aspects of the study in a language and in terms they could fully understand. Written informed consent was obtained prior to the patient’s participation. It was made clear to the patient that he could withdraw from the study at any time without explanation and that he would have no disadvantages from his withdrawal. The investigators involved performed the study in accordance with this protocol, ICH, GMP and all applicable regulatory requirements. The research protocol manager has ensured compliance with all procedures required by the protocol. We declare no conflict of interests. We declare no funding.

: Authors declare no financial interests that are directly or indirectly related to the work submitted for publication.