Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures Understands and is willing to sign an informed consent form (ICF) prior to initiation of any study-specific procedure. Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure; subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study requirements Able to understand and voluntarily sign the informed consent form, and able to comply with the study visit schedule and other protocol requirements; written informed consent obtained prior to any screening procedures Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Subjects must be able to understand and be willing to sign the written informed consent form; ideally, a signed informed consent form will be appropriately obtained prior to the conduct of any trial-specific procedure; however, if patients have had standard of care assessments performed within the screening period, but before the consent was signed, these will be admissible Are able to comprehend and willing to sign an informed consent form Patient able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure; subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study requirements Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Patients must be able to understand and be willing to sign the written informed consent form Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Able to understand and then sign an informed consent form (ICF) prior to initiation of any study-specific procedure and treatment. Subjects must be able to understand and be willing to sign the written informed consent form Patient is able to understand and is willing to sign the informed consent form Able to understand and sign a written informed consent form Willing and able to understand and sign the study specific Informed Consent Form Patient able to understand, sign, and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures Able to comprehend and willing to sign the informed consent form Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Be able to understand and willing to sign an informed consent form (ICF). Patient able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures Patients must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Able to comprehend and willing to sign an Informed Consent Form (ICF) Able to comprehend and willing to sign an informed consent form (ICF) Able to comprehend and willing to sign informed consent form Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure. Able to understand and willing to sign the informed consent form Able to comprehend and willing to sign the informed consent form Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Able to understand and willing to sign informed consent form (ICF) Able to comprehend and willing to sign an Informed Consent Form (ICF) Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Willing and able to understand and sign informed consent form Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Patient is aware of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Subjects or their guardians must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure. Patient must be willing and able to sign the informed consent form Written informed consent provided before any study-specific procedures are initiated. Subject must be able to understand and be willing to sign a written informed consent form. Able to comprehend and willing to sign the written informed consent form Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Able to understand and willing to sign the informed consent form Able to understand and sign a consent form Patient able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures Able to understand and willing to sign the informed consent form The subject has read and understood the written informed consent form (ICF) and is willing and able to give informed consent, fully understands the requirements of the trial and is willing to comply with all trial visits and assessments, including completion of patient-reported measures. Consent must be given before any trial related activities. Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Patients of their legal representatives must be able to understand and sign an informed consent form Able to understand and willing to sign an informed consent form (ICF) prior to initiation of any study-specific procedure and treatment The patient must be able to understand the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form Able and willing to sign protocol consent form Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Capacity to understand and sign the study informed consent form Willing and able to read, understand and sign an informed consent form (ICF) Willing and able to understand and sign consent form Willing and able to sign consent form. Understands the trial and procedure and is willing and able to sign the informed consent form Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form Subject must be willing and able (in the opinion of the investigator) to understand the informed consent form Subjects must be able to understand and willing to sign a written informed consent form