Consent will be administered by trained study physicians—each subject will be given the opportunity to read the IRB approved consent form and ask questions before being enrolled in the study. Consenting investigating physicians are all licensed medical doctors in the state of California and will be instructed to determine that the subject is competent before obtaining consent. After questions and concerns are answered, the patient will sign and date the consent form. This process will be witnessed, signed and dated by one of the clinic staff as well as the investigator.