Study design
RECRUITMENT, RECRUITMENT
The present study is a pilot two-arm randomized controlled trial, in compliance with CONSORT statements for pilot trials [Participation in the study was voluntary and participants gave their written informed consent prior to their inclusion in the study (all were of legal age). Recruitment was carried out between December 2020 and September 2021. The study protocol was approved by the hospital ethics committee prior to participant recruitment (Ref. 20/742-EC_X) and was conducted in compliance with the Declaration of Helsinki, and good clinical practice. Furthermore, the trial was pre-registered at ClinicalTrial.org (ID: NCT04690452).