Study design and ethics
This was a phase III, prospective, multicenter, single-blind, randomized, superiority clinical trial, conducted in four research centers in Brazil, between June 2016 and December 2017. The study was carried out in compliance with Good Clinical Practice, the International Council for Harmonization, and the Declaration of Helsinki and its amendments. The study protocol was approved by an independent local ethics committee (number 1.040.734), registered on 