The subject is capable of understanding and complying with the protocol and has signed the informed consent document The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document The subject is capable of understanding and complying with the protocol and has signed the informed consent document The subject is capable of understanding and complying with the protocol and has signed the informed consent document The subject is capable of understanding and complying with the protocol and has signed the informed consent document The participant is capable of understanding and complying with the protocol and has signed the informed consent document In the opinion of the Investigator, the patient is capable of understanding and complying with the protocol and has signed the informed consent document. Capable of understanding and complying with the protocol requirements and has signed the informed consent document. The participant is capable of understanding and complying with the protocol and has signed the informed consent document The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document Capable of understanding and complying with the protocol and has signed the informed consent document The patient is capable of understanding and complying with the protocol and has signed the informed consent document. A signed informed consent form must be obtained before any study-specific procedures are performed. Capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document. Subject is capable of understanding the informed consent process Capable of understanding and complying with the protocol requirements and has signed the informed consent document The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document Capable of understanding the informed consent and complying with the protocol and signed the informed consent document prior to any study-specific screening procedures or evaluations being performed The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document Capable of understanding and complying with the protocol requirements and has signed the informed consent document Participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document Capable of understanding and complying with the protocol requirements and has signed the informed consent document Capable of understanding and complying with the protocol requirements and has signed the informed consent document The participant is capable of understanding and complying with the protocol requirements and has signed the informed consent document The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document The patient is capable of understanding and complying with the protocol and has signed the informed consent document.