Consent documents and process All subjects for this study will be provided with a consent form describing this study and providing sufficient information for subjects to make an informed decision about their participation in this study. This consent form will be submitted with the protocol for review and approval by the REB for the study. The formal consent of a subject, using the REB approved consent form, must be obtained before that subject undergoes any study procedure. The consent form must be signed by the subject or by a legally acceptable surrogate, and the Investigator and/or designated research professional obtaining the consent. A copy of the signed and dated informed consent form must be given to the subject and the consent process must be documented.