TOGETHER Trial Master Protocol Versions

Version 2.0 - English March 2021 (First version)

Version 2.1 - English May 2021

Version 3.0 - English June 2021

Version 3.1 - English November 2021

Version 4.0 - English February 2022

Master protocol revision history - English

Institutional Review Board Approvals - Canada

HiREB - Hamilton Integrated Research Ethics Board, McMaster University

Initial Approval - English June 2021

Amendment 1 - English December 2021

Amendment 2 - English February 2022

TOGETHER Trial Protocol Versions (Brazil)

Version 1 - Portuguese (original) English (translation) January 2021

Version 2 - Portuguese (original) English (translation) March 2021

Version 3 - Portuguese (original) English (translation) April 2021

Version 4 - Portuguese (original) English (translation) May 2021

Version 5 - Portuguese (original) English (translation) December 2021

Version 6 - Portuguese (original) English (translation) January 2022

Version 7 - Portuguese (original) English (translation) March 2022

Institutional Review Board Approvals - Brazil

CONEP - Comissão Nacional de Ética em Pesquisa (National Research Ethics Committee)

Version 1 - Portuguese January 2021

Version 2 - Portuguese March 2021

Version 3 - Portuguese April 2021

Version 4 - Portuguese May 2021

Version 5 - Portuguese December 2021

Version 6 - Portuguese January 2022

Version 7 - Portuguese March 2022

TOGETHER Trial Statistical Analysis Plan (SAP) Versions

Version 1.0 - English March 2021

Version 1.1 - English May 2021

Version 2.0 - English June 2021

Version 3.0 - English February 2022