Patients must have voluntarily signed an informed consent in accordance with institutional policies. Subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them Subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them Subjects who have voluntarily signed a written informed consent in accordance with institutional policies after its contents have been fully explained to them Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained. Must understand and voluntarily sign an informed consent form after the contents have been fully explained to them Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained