All subjects over 18 yrs of age will be screened for eligibility relative to the patient inclusion and exclusion criteria. If a patient is eligible to enroll in the study, the nature and purpose of the study will be explained to the subject with a witness present. The subject will review and sign the written Informed Consent Form indicating informed and voluntary participation in the study. A copy of the consent form including all risks and benefits to the research subjects is attached as a separate document.