Data Sharing Statement
The first and last authors had full access to all the trial data and vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol. Deidentified data for the TOGETHER Trial arms are available to investigators upon request and pending a review process at Vivli (https://search.vivli.org). The study protocol and statistical analysis plan are available in the supplementary materials.
Contribution Statement
Dieter Ayers, Edward Mills, and Gilmar Reis had full access to all of the data and take responsibility for the integrity of the data and the accuracy of the analysis. All authors have read and approved this manuscript.
Concept and Design: Edward Mills, Gilmar Reis, Lindsay A Wilson, Dieter Ayers
Drafting of the Manuscript: Lindsay A Wilson, Dieter Ayers, Gilmar Reis, Edward Mills
Critical revision of the manuscript for important intellectual content: Gilmar Reis, Eduardo Augusto dos Santos Moreira Silva, Daniela Carla Medeiros Silva, Lehana Thabane, Jamie I. Forrest, Gordon H. Guyatt, Craig R. Rayner, Christopher Kandel, Mia J. Biondi, Robert Kozak, Bettina Hansen, M. Atif Zahoor, Paul Arora, Jordan J. Feld, Jeffrey S. Glenn
Acquisition, analysis, or interpretation of data: Gilmar Reis, Lindsay A Wilson, Dieter Ayers, Eduardo Augusto dos Santos Moreira Silva, , Eve Limbrick-Oldfield, Steve Kanters, Daniela Carla Medeiros Silva, Lehana Thabane, Jamie I Forrest, Ofir Harari, Adhemar Dias de Figueiredo Neto, Leonardo Cançado Monteiro Savassi, Aline Cruz Milagres, Maria Izabel Campos Simplicio, Luciene Barra Ribeiro, Rosemary Oliveira, Edward Mills
Administrative, technical, or material support: Eduardo Augusto dos Santos Moreira Silva, Daniela Carla Medeiros Silva, Lehana Thabane, Vitoria Helena de Souza Campos, Thiago Santiago Ferreira, Castilho Vitor Quirino dos Santos;Ana Maria Ribeiro Nogueira, Ana Paula Figueiredo Guimaraes Almeida,Leonardo Cançado Monteiro Savassi, Adhemar Dias de Figueiredo Neto, Ana Carolina Fialho Dias Rocha, Carina Bitarães, Aline Cruz Milagres,Eduardo Diniz Callegari, Maria Izabel Campos Simplicio, Luciene Barra Ribeiro, Carla Stefany Oliveira França, Rosemary Oliveira, Ofir Harari, Jamie I. Forrest, Hinda Ruton, Sheila Sprague, Paula McKay, Christina M. Guo, Josue R. Silva, Eve Limbrick-Oldfield, Steve Kanters, Gordon H. Guyatt, Craig R. Rayner.
Funded by Fastgrants, Bill & Melinda Gates Foundation, Eiger BioPharmaceuticals, Inc., FTX-Foundation; and the Rainwater Charitable Foundation.
Declaration of Interests
The authors confirm they have no conflicts of interest to declare.
Acknowledgements
The funders had no role in the design and conduct of the trial; the collection, management, analysis, or interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication.