Materials and methods
The Clinical Research Ethics Committee of the Valladolid East Health Area and the Spanish Agency for Medicine and Medical Devices (AEMPS) approved the study protocol, which followed European laws and the Declaration of Helsinki with its subsequent amendments. The Eudra CT number is 2016-003029-40 and the ClinicalTrials.gov Registry number is NCT03173638. Written consent was obtained from each patient prior to their participation in the study.