Ability to give informed consent Ability to provide informed consent Written informed consent Participant willing to provide a written informed consent Able to give informed consent Able and willing to sign informed consent/assent Provide informed written consent Provide informed written consent PROCUREMENT: Patient able to give informed consent TREATMENT: Patient able to give informed consent Ability to provide written informed consent Willing to provide informed written consent Ability to understand and the willingness to provide written informed consent to participate Inability to provide informed consent Provide informed written consent Ability to provide informed written consent Patients must be able to provide written informed consent Unable to provide informed consent Patient must have given written informed consent Ability to understand and willing to provide informed consent Participant is unable to provide informed consent Ability to provide informed consent; all subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed Patients must be able to provide written informed consent Patients must be able to provide written informed consent Inability to provide informed consent Inability to understand and inability to provide informed consent Patients must be able to provide written informed consent Capable and willing to provide informed consent Signed, written informed consent Inability to understand and sign informed consent Be able to provide written informed consent Written informed consent (IC) for trial participation must be signed and dated by the patient and the investigator prior to enrollment Any perceived inability to directly (and without the means of a legal guardian) provide informed consent Patients must be able to understand and sign an informed consent form Signed, dated informed consent The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines Written informed consent Patients must be able to provide written informed consent Patients must be able to provide written informed consent Patients must be willing and able to provide a written informed consent