 1.6 Informed Consent Patients andor their parents or legal guardians must be capable of understanding the investigational nature, potential risks and benefits of the study. All patients andor their parents or legal guardians must sign a written informed consent. Age appropriate assent will be obtained per institutional guidelines. To allow non-native speaking patients to participate in this study, bilingual health services will be provided in the appropriate language, when feasible, according to individual institutional practices and guidelines 