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Article History

Received: 27 April 2018

Accepted: 23 November 2018

First Online: 5 December 2018

Ethics approval and consent to participate

: The study was conducted following international and local ethical standards and regulations, and was approved by the Independent Ethics Committee from each participating institution before its beginning, with the following sites and their respective RECs: Hospital Heliópolis Research Ethics Committee (Centro Paulista de Investigações Clínicas Ltda.), Research Ethics Committee – UNICAMP (Instituto de Pesquisa Clínica e Assistência Medica de Campinas), Instituto do Câncer Dr. Arnaldo de Vieira de Carvalho Research Ethics Committee (Clínica Perdizes) and Faculdade de Medicina do ABC Research Ethics Committee (Instituto de Medicina Avançada).

: Not applicable.

: Dr. Andrea B. V. Lomonte was a medical-scientific advisor and was paid by Eurofarma Laboratórios S.A. to write the scientific article. Dr. José Alexandre Mendonça and Dr. Gilberto C. Brandão were investigators in that study and were paid by Eurofarma Laboratórios S.A. to conduct the clinical trial. Dr. Marise L. Castro was paid by Eurofarma Laboratórios S.A. to conduct the trial and she participates in clinical trials sponsored by Laboratórios Aché, Sanofi, Eurofarma, Eli Lilly and Amgen.

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