Document is current

Article History

Received: 1 September 2024

Accepted: 26 January 2025

First Online: 31 January 2025

Declarations

:

: The study protocol will be conducted to ensure adherence to the principles of Good Clinical Practice and procedures and to comply with Italian laws, as described in the following documents and agreed upon by the study investigators:1. ICH Harmonized Tripartite Guidelines for Good Clinical Practice 1996.2. D. L. n.211 del 24 giugno 2003.4. D. L. n.200 6 novembre 2007.5. D.M. 21 dicembre 2007.6. Legge n.189 8 novembre 2012.7. SPIRIT “Standard Protocol Items: Recommendations for Intervention trials”.The trial will be conducted according to the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act (WMO).Eligible participants will be told that they can withdraw from participating in the study when they change their mind in the time between having contact with the researcher, filling in the questionnaire and participating in the study as well as during the study.Data entry by study participants using the online process will be protected by the following measures:- network protection through a firewall;- encrypted Internet connection with digital certificate (SSL technology);- server on which the database is located protected by a periodically changed password;- access to the database protected by password and accessible only to the persons responsible for the study (Prof. Lasalvia and collaborators).The Promoter is committed to keeping a hard copy of the informed consent for at least 7 years in compliance with DL 200/2007. All computers in which the data will be stored, once downloaded by the person responsible for data management, will be protected by keywords. The local in which the computers are kept will be locked and protected by alarm systems if unattended. Responsible for the custody is the Principal Investigator (Prof. Antonio Lasalvia).The study was approved on August 13th, 2024, by the Ethics Committee of the South-West Veneto Area (approval No. 358CET). All participants will be asked to provide a written informed consent to participate in the study. Prof. Antonio Lasalvia is responsible for obtaining informed consent. The trial was registered on ClinicalTrials.gov, Identifier: NCT06567145; August 20, 2024.

: Not applicable.

: The authors declare that they have no competing interests.