Ethical considerations
This study was approved by the Research Ethics Committee of our
institution (process number XXXX) and registered at
ensaiosclinicos.gov.br (identifier: XXX). All participants signed the
consent form. The pharmaceutical company Eurofarma S.A. donated the
interventional drug and placebo and provided external support staff to
centralize randomization. Its company were not involved in study design,
intervention control, data management, or the manuscript.