Correa, Mateus Picada http://orcid.org/0000-0001-7131-3766
Motta-Leal-Filho, Joaquim M.
Lugokeski, Ricardo
Mezzomo, Marcio
Leite, Lucas Ricci
Article History
Received: 14 September 2021
Accepted: 31 January 2022
First Online: 18 March 2022
Declarations
:
: The authors declare that they have no conflict of interest.
: Written informed consent not applicable for this publication.
: This is a study protocol for a Randomized controlled trial. Informed Consent was created and approved at the University of Passo Fundo ethical committee. Protocol number: 4.364.391 / CAAE: 37590820.3.0000.5342. The trial was approved on Brazilian Registry of Clinical Trials (ReBEC) by the number RBR-2h5rwgb. This is the first version of the protocol. The Data Monitoring Committee is the ethical committee of University of Passo Fundo. Any adverse events will be reported to the committee and analyzed.
: GAUCHO trial is approved in the Ethic Committee of University of Passo Fundo with number 4.364.391 / CAAE: 37590820.3.0000.5342 and, registered onto the Registro Brasileiro de Ensaios ClĂnicos (ReBEC), with number RBR-2h5rwgb.