Institutional Review Board Statement
This clinical research adhered to the guidelines of the Declaration of Helsinki. The study’s protocol had received prior approval from the Vall d’Hebron Institutional Review Board (Comitè d’Ètica d’Investigació Clinica, Vall d’Hebron Institut de Recerca PR(AG)338/2016M, initially approved on 28 October 2016, and subsequently revised on 19 February 2022). All participants provided written consent prior to the commencement of any study procedures. The study protocol was registered with ClinicalTrials.gov under the identifier NCT05897411.