Ethics approval and consent to participate
Martorell
This study was conducted in accordance with Good Clinical Practice and all applicable regulatory requirements, including, where applicable, the current version of the Declaration of Helsinki. The protocol was approved by the following ethics committees: CEIm Hospital Universitario y Politécnico la Fe Avenida Fernando Abril Martorell; Bellberry Limited Human Research Ethics Committee; Melbourne Health Human Research Ethics Committee; Health and Disability Ethics Committee, and was monitored by a safety monitoring committee. Informed consent was obtained before patients participated in the study. The contents and process of obtaining informed consent(s) was in accordance with all applicable regulatory requirements.