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Article History

Received: 8 April 2021

Accepted: 7 October 2021

First Online: 30 October 2021

Declarations

:

: Ethical approval for this trial, which is in compliance with the Helsinki Declaration and in agreement with the SPIRIT statement, was obtained for the Ethics Committee of Cantabria on November 2, 2019 (acta 18/2019).The subsequent informed consent form will be obtained from all the participants. According to the current legislation regarding clinical trials (RD 1090/2015), the AEMPS will be notified of the start of the clinical trial. The obtained personal data and biological samples of all patients will be treated with confidentiality and security, in accordance with the regulations based on Law 15/1999 and Law 14/2007 on Biomedical Research.The sponsor will contract an insurance policy that will cover all possible damages that patients may suffer as a result of the application of the procedure understudy, in accordance with the applicable legislation, which will be periodically renewed during the entire duration of the study.

: Not applicable.

: Javier Crespo reports grants and research support from Gilead Sciences, AbbVie, MSD, Shionogi, and Intercept Pharmaceuticals (all outside the submitted work) and is a speaker for Gilead Sciences and AbbVie. The other authors declare that they have no competing interests.