Methods
This multi-centre clinical trial was approved by the research ethics boards of Mount Sinai Hospital (Toronto, ON), Western University (London, ON), and Hamilton Health Sciences (Hamilton, ON), which were sites where the study took place. The trial was registered at ClinicalTrials.Gov NCT02192424. It was conducted in accordance with Good Clinical Practice and the principles of the Declaration of Helsinki, and all participants provided written informed consent. The study protocol has been previously described in detail, along with reporting of the primary outcome