Bernocchi, Palmira http://orcid.org/0000-0003-0875-2007
Giudici, Vittorio
Borghi, Gabriella
Bertolaia, Patrizia
D’Isa, Salvatore
Trevisan, Roberto
Scalvini, Simonetta
Funding for this research was provided by:
Ministero della Salute (NET-2018-12367206-3)
Regione Lombardia (NET-2018-12367206-3)
Article History
Received: 29 December 2023
Accepted: 10 May 2024
First Online: 21 May 2024
Declarations
:
: The Central Ethics Committee of the Istituti Clinici Scientifici Maugeri in Pavia, Italy, approved this study (CEC n. 2338) on January 11, 2022. The Ethics Committee of Bergamo, Italy (CEC n. 49/22 and CEC. n.110/22), approved the study on July 22, 2022. The study was registered on 30/11/2022 at (NCT NCT05633784). The study will be conducted by the principles of GCP and the Helsinki Declaration. The participants will be recruited in the respective recruitment centers. All participants signed written informed consent before randomization. The data will be collected and processed minimally, and a participant code will link their information to the project, which will only be accessible to the project manager. Patient data will be securely stored for at least 10 years.
: Not applicable.
: The authors declare that they have no competing interests.