2.1. Trial Oversight
A prospective, randomized, non-blinded clinical trial was carried at Sagunto Hospital, Valencia, Spain. The study was approved by the Clinical Research Ethics Committee of Sagunto Hospital on 31 March 2020 (FXC-30 March 2020) and endorsed by the local ethics committees. The trial was performed in accordance with the principles of the Declaration of Helsinki and registered in the ClinicalTrials.gov registry with the following identifier number: NCT04666116. Heel España S.A.U. laboratories had no influence on the trial design or execution and was not involved in the data collection or analysis, the writing of the manuscript or the decision to submit it for publication. The authors assume responsibility for the accuracy and completeness of the data and analyses, as well as for the fidelity of the trial and this report to the protocol. The trial protocol is available at NEJM.org.