Ethical approval
This material has not been published previously, in whole or part, and is not under consideration for publication elsewhere. This paper has no tables or figures that would require permission to reprint. The authors have no conflict of interest to declare. All authors participated in the preparation of this manuscript, fulfilled the criteria for authorship, and approved the paper in the current format. The study conforms to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in the prior approval by the institution’s human research committee. This study was not supported by any grant. The trial registration number at ClinicalTrials.gov was NCT03470454.