Ethics approval and consent to participate
REVISE is approved by Health Canada [HC6-24-c210404], Clinical Trials Ontario Research Ethics Project ID: 1360, the Northern Sydney Local Health District Human Research Ethics Committee (HREC) [2019/ETH08405], and Comissão Nacional de Ética em Pesquisa (CONEP) [5.734.590]. Regulatory oversight is by Health Canada [HC6-24-c210404]. All participating centers have local ethics approval.