Subjects must be willing and able to sign the informed consent and comply with the study protocol. Able to agree to and sign informed consent and to comply with the protocol Able to understand and voluntarily sign the ICF and able to comply with the study visit schedule and the other protocol requirements. Willing and able to comply with the protocol and sign informed consent Patient has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements Patient has signed the informed consent prior to any screening procedures being performed and is able to comply with the protocol 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 Able to understand and voluntarily sign a written informed consent, and willing and able to comply with protocol requirements Able to understand and voluntarily sign a written informed consent, and willing and able to comply with protocol requirements Ability to understand and the willingness to sign a written informed consent document; subject has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements Capability to understand and comply with the protocol requirements as and signed informed consent documents Capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document. Patient has signed informed consent and is willing to comply with the protocol Patients must be willing and able to give written informed consent prior to any protocol-specific procedures being performed and comply with the protocol requirements for the duration of the study. Ability to understand and the willingness to sign a written informed consent document; subject has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements Patient has signed the informed consent form prior to the performance of any screening procedures and is able to comply with protocol requirements. Patient has signed the Informed Consent Form (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements Patient has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirement Willing and able to sign written informed consent and be able to comply with the study protocol for the duration of the study Patient has signed the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements. Patient must be able to give informed consent and comply with the treatment protocol and follow-up plan. Able to understand and voluntarily sign the informed consent form, and able to comply with the study visit schedule and other protocol requirements Able to sign informed consent and to comply with the protocol Willing and able to comply with the protocol and sign informed consent able understand and give written informed consent and comply with the study protocol. Patients must be willing and able to provide signed informed consent and comply with the study protocol. Willing and able to sign the informed consent and to comply with the protocol for the duration of the study. Able to sign informed consent and to comply with the protocol Able to sign informed consent and to comply with the protocol Able to understand and comply with the protocol requirements and has signed the informed consent document. Patients able to render informed consent and to follow protocol requirements Willingness to sign informed consent and comply with all protocol requirements Ability to understand and the willingness to sign a written informed consent document; patient must sign the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements. Cohort A Only: Signed written informed consent and willingness to comply with protocol requirements Patient has signed the informed consent (ICF) and is able to comply with protocol requirements Is able to agree to and sign informed consent and to comply with the protocol