dos Santos, Daiane Santos http://orcid.org/0000-0001-5194-2020
Duppre, Nádia Cristina
Sarno, Euzenir Nunes
Pinheiro, Roberta Olmo
Sales, Anna Maria
Nery, José Augusto Da Costa
Moraes, Milton Ozório
Camacho, Luiz Antônio Bastos
Funding for this research was provided by:
Carlos Chagas Filho Foundation for Research Support of the State of Rio de Janeiro (BRL 112.436,00)
Article History
Received: 6 June 2017
Accepted: 28 March 2018
First Online: 23 April 2018
Ethics approval and consent to participate
: The present study was approved by the Ethics Committee of the Oswaldo Cruz Institute (IOC/FIOCRUZ) under the registration numbers CAAE 41678415.8.0000.5248 (19 June 2015) and CAEE 53520016.4.0000.5248 (17 January 2017), and registered on the platforms of the Brazilian Registry of Clinical Trials (ReBEC) under number RBR-69QK5P on 1 June 2017. The study follows the standards established in the Declaration of Helsinki, Good Clinical Practice Guidelines and Document of the Americas (Pan American Health Organization, 2005). It abides by the Brazilian ethical norms (Resolution CNS No. 466/12 and Resolution CNS No. 510/16) regulating research on human beings. Candidates are duly informed that their participation in the study is totally voluntary and that they may leave the study without any restrictions in the health care they receive from then on. Support during the follow-up period to manage the occurrence of any adverse events and evaluate any suspected cases of leprosy is assured. The study procedures will ensure the privacy rights of all participants (locked file cabinets and free access to the study dataset). The results of this research will only be presented in an aggregate way to prevent any personal identification of the participants.A data monitoring committee comprising independent experts in leprosy control, clinical research, and statistics will oversee the study development. They will receive timely reports of protocol amendments, incidents, and adverse events and data analysis. The committee’s meetings will be convened to assess interim and final analyses and their results.
: The authors declare that they have no competing interests.
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