Evidence of a signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study Show evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment. Ability to understand and willingness to sign a written informed consent document indicating that the patient has been informed of all pertinent aspects of the trial prior to enrollment Signed and dated informed consent form indicating that the patient has been informed of all pertinent aspects of the trial prior to enrollment Signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial prior to randomization Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment Provide signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment Must provide a signed and dated informed consent indicating that the participants has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating. Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to undergoing study screening procedures Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment Evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial Signed and dated informed consent indicating that the subject (or legally acceptable representative if applicable by local laws) has been informed of all the pertinent aspects of the trial prior to enrollment Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. Evidence of a personally signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial