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Article History

Received: 24 March 2022

Accepted: 16 June 2022

First Online: 27 June 2022

Declarations

:

: This study was approved by the Ethics and Research Committee of the "Hospital Universitario y Politécnico La Fe" on January 23, 2019, and by the Research Commission of “Instituto de Investigación Sanitaria La Fe”. This study complied with the fundamental principles established in the Declaration of Helsinki (in the Council of Europe Convention on human rights in biomedicine) set out in the UNESCO Universal Declaration on the human genome and human rights. It also satisfied the requirements established by legislation on Data Protection Law 15/1999 of 13 December, regarding biomedical research, personal data protection, and bioethics. This study was approved by the Research Commission and the Research Ethics Committee and was registered as a clinical trial at Clinicaltrials.gov with registration number NCT03456414.All eligible patients received verbal and written information about the study. All participants signed the informed consent.

: Not applicable.

: The authors have no conflicts of interest in relation to this present study.