Funding for this research was provided by:
Received: 20 April 2019
Accepted: 22 July 2019
First Online: 31 July 2019
Ethics approval and consent to participate
: The ADDENDA-BHS2 trial was registered at Clinicaltrials.gov in September 29, 2016 by the number NCT 02919345, as a single-center, randomized, open, active-controlled, phase-4 trial. The Institutional Ethics in Research Committee of the Universidade Estadual de Campinas (State University of Campinas-UNICAMP) approved the study (CAAE41618915.1.0000.5404). Accordingly, all patients signed an informed consent term and all methods were performed in accordance with the relevant guidelines and regulations. The first trial randomization occurred at July 27th 2017. The protocol was not modified since the first submission for IERC.
: Not applicable.
: The BHS received grant support from AstraZeneca to conduct the Addenda trial. The authors declare that they have no competing interests.