Trial design and ethical approval
SECONDARY
This was a multicenter randomized controlled clinical trial, with two-arm parallel groups (1:1 allocation rate) with one year of follow-up, registered in the clinical trials database (ClinicalTrials.gov: NCT02782390). The secondary outcomes foreseen in the protocol will be further analysed and published. The manuscript was reported following the Consolidated Standards of Reporting Trials (CONSORT) guideline.