Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
SAFETY RUN-IN: Signed written informed consent in accordance with regulatory and institutional guidelines
RANDOMIZED PHASE II CLINICAL TRIAL: Signed written informed consent in accordance with regulatory and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Informed and must sign and give written informed consent in accordance with institutional and federal guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
DONOR: Documented informed consent per local, state and federal guidelines
Written 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)
Signed informed consent form in accordance with institutional and federal law policies
Written informed consent in accordance with federal, local, and institutional guidelines
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines.
Recipient must have signed a voluntary, informed consent in accordance with institutional and federal guidelines
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines
Subjects must sign a written informed consent in accordance with institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Signed written informed consent per institutional and federal regulatory requirements
Written informed consent in accordance with institutional guidelines.
Signed, written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
Signed informed consent in accordance with federal, local, and institutional guidelines
Signed, written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Signed written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines; the patient must provide informed consent prior to the first screening procedure
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines.
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent following institutional and federal guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Written informed consent in accordance with institutional guidelines
Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
Be capable of signing and providing written consent in accordance with institutional and federal guidelines
Written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines
All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
Patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
All 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 study
All 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 patient
All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
Consent: all patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines
All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
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 guidelines
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
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
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.
Patients 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 form
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 form
STEP 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 form
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 guidelines
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
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
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
REGISTRATION 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 guidelines
Patients 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 guidelines
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
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
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
Patient 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
ALL 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 guidelines
All 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
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 guidelines
Subjects 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
All 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 guidelines
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 guidelines.
Patients 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 protocol
DONOR: 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 institution
All 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
Ability 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 guidelines
Patient 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
Sign (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 study
The 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 guidelines
DONOR: 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 Guidelines
Patient 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 study
All 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.
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
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 guidelines
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
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
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
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
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 guidelines
Patients must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rules
Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional standards and federal guidelines
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
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 guidelines; for all patients the appropriate consent form for this registration is the Step 2 Consent
Patients 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 guidelines
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 guidelines
Patients 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 guidelines
REGULATORY 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 guidelines
All 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
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
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
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
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 guidelines
All 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
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 guidelines
All patients must be informed of the investigative nature of the clinical trial and give written informed consent in accordance with institutional and federal guidelines
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 guidelines; for all patients, the appropriate consent form for this registration is the Step 2 Consent Form
All 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
Patients 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 guidelines
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 screening procedures
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 guidelines
All 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 ineligible
All patients must be informed of the investigational nature of this study and must sign and give written consent in accordance with institutional and federal guidelines
All 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 guidelines
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 guidelines
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
All 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
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
Patients must be informed of the investigational nature of this study and sign written informed consent in accordance with institutional and federal guidelines
Signed informed consent that details the investigational nature of the study according to institutional and federal guidelines
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
REGULATORY 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 guidelines
All 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 guidelines
All patients must be informed of the investigative nature of the clinical trial and give written informed consent in accordance with institutional and federal guidelines
All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
All 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 regulations
All 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 guidelines
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
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
All 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 entry
Patient 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 study
All 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 guidelines
Be 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 procedures
All 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 guidelines
Subjects must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rules
Participants 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 procedures
All 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
All 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
All 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
Patients 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) guidelines
Participants 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 procedures
Participants 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 procedures
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 procedures
Participants 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 procedures
Participants 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 procedures
Participants 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 procedures
Participants 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 procedures
Participants 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 procedures
Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines
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 screening procedures
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 screening procedures
BIODISTRIBUTION 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 procedures
DYNAMIC 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 procedures
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
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 guidelines