 - Informed ConsentAssent: Able to give written informed consentassent prior to participation in the core study, which will include the ability to comply with the requirements and restrictions listed in the consentassent form and in this protocol. Participants must be able to read, comprehend, and write at a level sufficient to complete study related materials. Written informed consent must be obtained from ALL patientslegally authorized representatives; for patients 12-17 years old, written informed assent must be obtained in addition to the legally authorized representatives consent. 