Written informed consent (assent if applicable) and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the patient's parent or legal guardian; [clinicaltrials_resource:980feca3e3111bf4d66f22de3a21dcef]

Written informed consent (assent if applicable) and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the patient's parent or legal guardian; [clinicaltrials_resource:980feca3e3111bf4d66f22de3a21dcef]