Institutional Review Board Statement
The clinical study was conducted according to the Declaration of Helsinki. The study protocol had previously been approved by the Institutional Review Board of the University Hospital Vall d’Hebron (Comitè d’Ètica d’Investigació Clinica, Vall d’Hebron Institut de Recerca; protocol number PR(AG)338/2016M approved 28 October 2016, revised 11 December 2020) and all participants provided written informed consent. The study protocol was registered with 