All adverse events will be documented and appropriately described. The severity of the adverse event will be coded as mild, moderate, or severe; the association with the intervention will be coded as not related, possibly related or related. The determination of the severity and association will be decided by the principal investigator (PI). The PI for this study will also be acting as the safety monitor, reviewing all adverse events. All serious adverse events that are unexpected and potentially related to the research will be reported in an expedited manner to the research ethical board, the other participating centre and Health Canada.