All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.Xx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines; for step 1 initial registration, the appropriate consent form is the step 1 consent formXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; the appropriate consent form for this registration is the step 2 consent formXx_NEWLINE_xXSTEP 3 CROSSOVER REGISTRATION (OPTIONAL): Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; the appropriate consent form for this registration is the step 2 consent formXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXREGISTRATION STEP 2-RANDOMIZATION: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXALL PATIENTS: Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXInformed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.Xx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXInformed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXThe patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAbility to provide written informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXSAFETY RUN-IN: Signed written informed consent in accordance with regulatory and institutional guidelinesXx_NEWLINE_xXRANDOMIZED PHASE II CLINICAL TRIAL: Signed written informed consent in accordance with regulatory and institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXBe capable, willing, and able to provide written informed consent/assent. For patients < 18 years of age, their parents or legal guardians must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.Xx_NEWLINE_xXInformed and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXSubjects or their legally authorized representative must be informed of the investigational nature of this study, and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXInformed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.Xx_NEWLINE_xXAll subjects must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAble to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXPatients who give a written informed consent obtained according to local guidelinesXx_NEWLINE_xXPatients must consent to be in the study and must have signed and dated an approved consent form, which conforms to federal and institutional guidelinesXx_NEWLINE_xXAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXPatients must be able to provide informed consent and be willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXSubjects must be informed of the investigational nature of this study, and must sign and give written informed consent in accordance with institutional and federal guidelines.Xx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXSTUDY TREATMENT: Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXDONOR: Documented informed consent per local, state and federal guidelinesXx_NEWLINE_xXPatients must be informed of investigational nature of this study and must be willing to give written informed consent in accordance with institutional and federal guidelines. Patients must be able to comply with the requirements and assessments of the study protocolXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure. However, the Investigator should not repeat procedures that are performed as part of standard of care (SOC), if they are within the screening window and are done prior to signing the informed consent form (ICF)Xx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate will be obtained according to institutional guidelinesXx_NEWLINE_xXSigned informed consent form in accordance with institutional and federal law policiesXx_NEWLINE_xXPatients who give a written informed consent obtained according to local guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines; patient must sign an informed consent document indicating that they understand the purpose of and procedures required for the study, and are willing to participate in and comply with the guidelines of the studyXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines; a copy of the informed consent document signed by the patient must be given to the patientXx_NEWLINE_xXDONOR: The donor must have been informed of the investigational nature of this study and have signed a consent form in accordance with federal guidelines and the guidelines of the participating institutionXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign and\\ give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent will be obtained, when appropriate, according to institutional guidelinesXx_NEWLINE_xXAll subjects and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAbility to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXAbility to consent to treatment - patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatient and/or parents or authorized legal representative have signed a written informed consent/assent per institutional guidelinesXx_NEWLINE_xXPatient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXSign (or their legally-acceptable representatives must sign) an informed consent document in accordance with institutional and federal guidelines indicating that they understand the investigational nature of and procedures required for the study, including biomarkers, and are willing to participate in and comply with the guidelines of the studyXx_NEWLINE_xXConsent: all patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXThe patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelinesXx_NEWLINE_xXCOHORT II: The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXInformed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines.Xx_NEWLINE_xXAble to comprehend and provide written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXThe recipient and/or the recipient's legal guardian must have been informed of the investigational nature of this study and have signed a consent form which is in accordance with Federal guidelinesXx_NEWLINE_xXDONOR: The donor, or legal guardian, must have been informed of the investigational nature of this study and have signed a consent form in accordance with Federal GuidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXPatient must be informed of the investigational nature of this study in accordance with institutional and federal guidelines and have the ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the studyXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.Xx_NEWLINE_xXAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXWritten, informed consent according to institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXThe patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelinesXx_NEWLINE_xXAble to comprehend and provide written informed consent in accordance with institutional and federal guidelines.Xx_NEWLINE_xXRecipient must have signed a voluntary, informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAble to comprehend and provide written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAble to comprehend and provide written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXSubjects must sign a written informed consent in accordance with institutional guidelinesXx_NEWLINE_xXSubject (or legal guardian) must sign a written informed consent in accordance with institutional guidelinesXx_NEWLINE_xXInformed consent: All participants and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines. Participants must be willing to comply with all aspects of the protocol.Xx_NEWLINE_xXAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXPatients must consent to be in the study and sign an approved consent form conforming with institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXSigned written informed consent per institutional and federal regulatory requirementsXx_NEWLINE_xXWritten informed consent in accordance with institutional guidelines.Xx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXWritten informed consent according to institutional guidelines, andXx_NEWLINE_xXSubjects or their legal guardian must sign a written informed consent in accordance with institutional guidelinesXx_NEWLINE_xXAll patients or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXSigned, written informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines; patients must be willing to comply with all aspects of the protocolXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rulesXx_NEWLINE_xXAll patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional standards and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for Step 1 registration of patients who have not yet submitted specimens for the Oncotype DX Breast Cancer Assay, the appropriate consent form is the Step 1 Consent Form; for both Step 1 and Step 2 registration of patients whose Recurrence Score is already known and is 25 or less, the appropriate consent form is the Step 2 Consent FormXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for all patients the appropriate consent form for this registration is the Step 2 ConsentXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent prior to any study-related procedures in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelinesXx_NEWLINE_xXREGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients must be informed of the investigative nature of the clinical trial and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXInformed Consent Signed informed consent according to institutional guidelines must be obtained. Assent, when appropriate, will be obtained according to institutional guidelines.Xx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for Step 1 Initial Registration of patients who have not yet submitted specimens for the central BRAFV600E testing, the appropriate consent form is the Step 1 Consent Form; for both Step 1 Initial Registration and Step 2 Randomization of patients whose BRAF mutation status is already known, the appropriate consent form is the Step 2 Consent FormXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; for all patients, the appropriate consent form for this registration is the Step 2 Consent FormXx_NEWLINE_xXAll patients and/or their legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAbility to provide written informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXSigned informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXSigned, written informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent prior to any screening procedures in accordance with institutional and federal guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXBe informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening proceduresXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients must be informed and must sign and give written informed consent in accordance with institutional and federal guidelines; patients who are unable to comply with study and/or follow-up procedures are ineligibleXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign and give written consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXSigned written informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAbility to give written informed consent according to local guidelinesXx_NEWLINE_xXAll patients must demonstrate the ability to understand the investigational nature of this study and must sign a written informed consent document in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelines; the patient must provide informed consent prior to the first screening procedureXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXWritten informed consent according to institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAble to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAble to understand and have signed an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and sign written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAble to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXSigned informed consent that details the investigational nature of the study according to institutional and federal guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients, or their legal guardians, must sign a written informed consent in accordance with institutional guidelinesXx_NEWLINE_xXProspective study participants must be informed of the investigational nature of the study and must have signed an Institutional Review Board (IRB)-approved informed consent form in accordance with institutional and federal guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXREGULATORY CRITERIA: Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAble to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study; patients or a legally authorized representative must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigative nature of the clinical trial and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelines.Xx_NEWLINE_xXSigned informed consent according to institutional guidelines must be obtained; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal regulationsXx_NEWLINE_xXAble to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAble to provide informed consent and have signed an approved consent form that conforms to federal and institutional guidelinesXx_NEWLINE_xXWritten informed consent following institutional and federal guidelinesXx_NEWLINE_xXWritten informed consent in accordance with institutional and Food and Drug Administration (FDA) guidelines must be obtained from parent or legal guardianXx_NEWLINE_xXAll patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXWritten informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of the study and standard alternative therapies; all patients must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAble to give assent according to institutional guidelinesXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign a study specific informed consent in accordance with institutional and federal guidelines prior to study entryXx_NEWLINE_xXPatient must be informed of the investigational nature of this study in accordance with institutional and federal guidelines and have the ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the studyXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXWritten informed consent and assent as required by institutional guidelinesXx_NEWLINE_xXAll patients and/or their parents or legal guardians must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAll patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXBe informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to any study specific proceduresXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign and give written informed consent for aim 1 study activities in accordance with institutional and federal guidelinesXx_NEWLINE_xXSubjects must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rulesXx_NEWLINE_xXParticipants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific proceduresXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXAll patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXWritten informed consent in accordance with institutional and FDA (food and drug administration) guidelines must be obtained from all subjects (or patients' legal representative).Xx_NEWLINE_xXWritten informed consent in accordance with institutional guidelinesXx_NEWLINE_xXInformed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXInformed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXAbility to provide written informed consent in accordance with federal, local, and institutional guidelinesXx_NEWLINE_xXInformed Consent: All patients and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelinesXx_NEWLINE_xXPatients must be fully informed of the investigational nature of this study and must sign an informed consent in accordance within institutional and Food and Drug Administration (FDA) guidelinesXx_NEWLINE_xXBe capable of signing and providing written consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXParticipants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific proceduresXx_NEWLINE_xXParticipants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific proceduresXx_NEWLINE_xXParticipants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific proceduresXx_NEWLINE_xXParticipants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific proceduresXx_NEWLINE_xXParticipants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific proceduresXx_NEWLINE_xXParticipants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific proceduresXx_NEWLINE_xXParticipants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific proceduresXx_NEWLINE_xXParticipants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific proceduresXx_NEWLINE_xXBe informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXWritten, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelinesXx_NEWLINE_xXBe informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening proceduresXx_NEWLINE_xXBe informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening proceduresXx_NEWLINE_xXBIODISTRIBUTION COHORT: Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific proceduresXx_NEWLINE_xXDYNAMIC COHORT: Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific proceduresXx_NEWLINE_xXPatients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xXPatients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelinesXx_NEWLINE_xX