Ethics approval and consent to participate
MAY
Ethical approval was obtained from the Comitè Ètic d’Investigació Clínica of Hospital Universitari Mútua Terrassa (Barcelona; ref approval no. 05/2019), on May 22, 2019, reference number 05/2019. Written informed consent to be obtained from each patient before randomization. Any subsequent amendments of the protocol need to be approved by the relevant ethical bodies before implementation.