Provided informed consent Informed consent provided Written informed consent provided prior to the initiation of study procedures Written informed consent provided. Provided written informed consent Has provided written informed consent for participation in this trial Subject has provided written informed consent Have provided written informed consent Must have provided written informed consent prior to participating in any study-related activity. Have provided written consent for protocol directed biopsies Have provided written informed consent. All patients must have provided informed consent for correlative studies Subject has provided informed consent Has provided written informed consent prior to completing any study procedures There will be no upper age limit for eligibility; elderly patients will be eligible for participation provided they are competent to provide informed consent, or written consent can be provided by their duly appointed healthcare proxy Have provided informed consent Written informed consent provided Provided written consent Written informed consent provided Written informed consent must be provided. Must have provided informed consent for study participation. Has provided written informed consent prior to any study related activities. Subject has provided informed consent or subject's legally acceptable representative has provided informed consent when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent. Written informed consent provided. Has provided written informed consent Subject has provided informed consent. Has provided written informed consent Subject must have provided written Informed Consent Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities; Subject has provided written informed consent with HIPAA authorization Subject has provided written informed consent to participate in the study Subject has provided written informed consent to participate in the study Patients who have provided informed consent for the long term follow up study prior to their study participation .