Lopes, Carla Pinheiro http://orcid.org/0000-0002-3383-9019
Danzmann, Luiz Claudio
Moraes, Ruy Silveira
Vieira, Paulo José Cardoso
Meurer, Francisco França
Soares, Douglas Santos
Chiappa, Gaspar
Guimarâes, Luciano Santos Pinto
Leitão, Santiago Alonso Tobar
Ribeiro, Jorge Pinto
Biolo, Andreia
Funding for this research was provided by:
Fundo de Incentivo à Pesquisa e Educação (11-0069)
Article History
Received: 9 March 2017
Accepted: 9 July 2018
First Online: 28 July 2018
Ethics approval and consent to participate
: All participants will read and sign an informed consent form before beginning the study. All team members have been trained to introduce, show and take questions about the informed consent, exams to be performed, and eventually discomforts associated to interventions before patients signing the informed consent. The study protocol has been approved by the HCPA Institutional Review Board (protocol number 11–0069) and will be conducted according to the principles of the Declaration of Helsinki and in compliance with the Brazilian legal and regulatory framework for research involving human beings.This protocol was registered in the ExternalRef removed under identifier number NCT03028168 (January 16, 2017) and in the Brazilian Records of Clinical Trials (REBEC) with the identifier number: RBR-64mbnx (19 August 2012) and the last update was performed on September 2, 2013.The ethical bodies of the Hospital de Clínicas de Porto Alegre (IRB 00000921) and from Hospital ULBRA-Mãe de Deus (Registration Number at Plataforma Brasil: 5349).For their own safety, patients will be followed up after the end of the protocol in the outpatient services of the Hospital de Clínicas of Porto Alegre and the University Hospital ULBRA-Mãe de Deus.
: The consent for publication was included in the consent to participate form.
: The authors declare that they have no competing interests.
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