 After the initial screening process, if the potential subject meets the inclusionexclusion criteria and does not object to learning more about the study during initial discussion with their primary provider, then one of the key personnel trained and authorized to consent will approach the potential subject to discuss the study by explaining the following: the purpose of the study and the future benefits it may provide in subsequent patients, the prospective and observational nature of the study, the study procedures, the risks of loss of confidentiality, and the safeguards against that risk. All information will be clearly printed in plain language on the consent form. The potential subject will then be given the choice to enroll in the study. 