Trial design
RESOLUTION
The current open clinical trial was carried out at the Maria Aparecida Pedrossian University Hospital (HUMAP) with approval from the National Research Ethics Committee (CONEP) and the Human Research Ethics Committee (CEP) of the Federal University of Mato Grosso do Sul (CEP/CONEP) under No. 2,745,746. The study was carried out in accordance with Resolution No. 466 of the National Health Council (Brasil, 2012) and registered in ISRCTN 23909398 and in the Brazilian Registry of Clinical Trials—REBEC—RBR-10bk2qbb.