2. Patients who are 18 years of age or older must have provided IRB approved written informed consent. Patients between the ages of 12 to 17 years of age must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the patient's legally acceptable representative (i.e., parent or guardian). In addition, all patients or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization, if applicable