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Authors
Lo Coco, Gianluca https://orcid.org/0000-0001-9027-1899
Albano, Gaia
Gullo, Salvatore
Cardi, Valentina
Segura-Garcia, Cristina
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Funding
Funding for this research was provided by:
Ministero dell’Istruzione, dell’Università e della Ricerca (P202237PFB, P202237PFB, P202237PFB)
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Article History
Received: 17 January 2025
Accepted: 14 June 2025
First Online: 23 June 2025
Declarations
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: The Ethics’ Committee of the Catanzaro Region has granted ethical approval to the study (protocol number 221 27.06.2024). Study psychiatrists will discuss informed consent in detail with potential participants, including a discussion of any questions/concerns regarding the study. Participants will commence study participation once written informed consent is obtained. Both prior to signing the consent form, and on the form itself, it will be made clear to potential participants that entry into the study is voluntary and if they opt not to participate this will in no way affect their relationship with the hospital or study investigators/clinicians.
: N/A.
: The authors declare no competing interests.
: To ensure confidentiality, all data collected will be pseudonymized. The digital platform is validated according to GMP Annex 11 and FDA CFR 21 Part 11 and compliant with GDPR. Research data will only be accessible to staff involved in the study as needed. Where participant consent is provided for data to be re used and shared with other researchers for future research projects, data will only be provided in a de-identified format and with separate ethics approval.
