Ability to understand and the willingness to sign a written informed consent document; if a patient has impaired decision-making capacity, a legally authorized representative, patients will be allowed to participate Ability of subject or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document Ability of subject or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document Ability of subject or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document Ability of a patient or a Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document