Signed, written IRB-approved informed consent Patients must have signed an approved informed consent Patients must have signed an approved informed consent Patients must have signed an approved informed consent Patients must have signed an approved informed consent Signed, written IRB-approved informed consent. Patients must have signed an approved informed consent Patients must have signed an approved informed consent An approved informed consent must be signed by the patient Patients who have signed an approved Informed Consent Signed, approved Informed Consent. Patients must have signed an approved informed consent Patients must have signed an approved informed consent. Voluntary signed, written IRB-approved informed consent. Patients who have signed an approved informed consent form