Confidentiality All participants will be identified in the study by their initials and assigned patient study number. Only study personnel will have access to study-related records during the conduct of the study. The contents of study related records will not be available to any party other than the University of Saskatchewan Ethics Board, the study sponsor, and government regulatory agencies unless required by law. A report of the results of this study may be made to Health Canada (HC) and the Food and Drug Administration (FDA, USA) while maintaining confidentiality of patient identification. The results of this study may also be used for medical and scientific publications but patient identity will not be disclosed. Study files will be archived by the scientific investigator for 25 years at Royal University Hospital.