Design
This design of this 2-armed randomized clinical trial has been approved by the Research Ethics Committees of Hospital Clínic i Universitari (no. 2020/350) and Hospital Politècnic i Universitari from Valencia (no. 2021-001-1), ensuring compliance with the ethical and legal provisions of the research. The experiments will be performed in accordance with the principles of the Declaration of Helsinki. The study has been prospectively registered (clinicaltrials.gov id. NCT05363137). Informed consent will be obtained from participants. The Universitat de València is responsible for the integrity and conduct of the study, which started on September 2022. The intervention period, in which participants will took part sequentially, will end approximately one year later, while the follow-up extends up to one year after enrolling the last participant.