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Article History

Received: 8 March 2022

Accepted: 25 November 2022

First Online: 12 December 2022

Declarations

:

: The study will be carried out respecting the fundamental principles established in the Declaration of Helsinki (1964), the Council of Europe Convention on Human Rights and Biomedicine (1997), the UNESCO Universal Declaration on the Human Genome and Human Rights (1997). Research will also follow the requirements established by Spanish legislation (Organic Law 3/2018 of 5 December and Law 41/2002 of 14 November). This study protocol has been registered in the platform clinicaltrials.gov (No. reg. NCT04366401; First Submitted: 28/04/2020; First Registration: 25/06/2020). The study received ethical approval from Zamora Health Area Drug Research Ethics Committee at the Regional Government of Castile and León, Spain (No. reg. 468). All the information analysed by the principal investigator of this study is subject to the maintenance of professional secrecy.In any case, each participant must agree to participate in the study and sign the informed consent form (the patient can refused to participate in the study at any time) and will be assigned a code as a registry, where all the relative data will be mechanized in an anonymous way, delimiting the access to the database only to the personnel linked to the development of the study, previous authorization of the investigator in charge of it.

: Not applicable.

: The authors declare that they have no competing interests.