Provide informed written consent Provide written informed consent Provide informed written consent Provide written informed consent Subjects must provide written informed consent to participate Must provide written informed consent. Provide written informed consent Provide written informed consent Willingness to provide informed written consent Patients who can provide informed consent Patients must provide written consent Participant must voluntarily agree to provide written informed consent Provide written informed consent Provide informed written consent Provide informed consent Provide informed written consent Provide informed written consent Provide informed written consent Provide informed written consent Provide informed written consent Provide informed written consent Patients must provide written informed consent. Provide written informed consent for the follow up protocol. Refusal to provide written informed consent Patients must provide informed consent Provide written informed consent Provide written informed consent Provide written informed consent Provide written informed consent Provide informed written consent Provide written informed consent Provide informed written consent Provide written informed consent Provide informed written consent Provide informed written consent Provide written informed consent Provide written informed consent Provide informed written consent Provide informed written consent Provide informed written consent Provide written informed consent Patients must provide written informed consent Provide written informed consent Patients must provide written informed consent. The patient must provide informed consent. Provide informed written consent Provide informed written consent Patients must provide informed written consent Patients must provide written informed consent Provide informed written consent Patients must provide informed written consent Patients must provide written informed consent Provide informed written consent Patients must provide written informed consent Provide written informed consent for the trial Provide informed written consent Must provide written informed consent Participant must provide informed consent Patients must provide written informed consent Provide informed written consent For Phase I and II: Patients must provide written informed consent. Subjects who provide written informed consent to participate in the study Willingness to provide written informed consent for the study. Provide written informed consent prior to any study related procedure. Provide informed written consent Provide written informed consent to participate on the study Patients must provide written consent Provide written informed consent Provide written informed consent Provide written informed consent Participant unwilling to provide written informed consent Patients must provide written informed consent. Provide written informed consent Can provide informed consent Provide written informed consent Provide written informed consent Provide informed written consent Provide informed written consent Provide informed written consent Patients must provide informed written consent Provide written informed consent Provide informed written consent Willingness to provide informed consent Provide written informed consent Provide written informed consent Patients must provide verbal and written informed consent to participate in the study Patients must provide written informed consent. Willingness to provide written informed consent for the study. Provide informed written consent Participant must voluntarily agree to provide written informed consent. Patients must provide written informed consent Patients must provide written informed consent Provide written informed consent Provide written informed consent Provide informed written consent Provide informed written consent Provide written informed consent Provide informed written consent Provide informed written consent Provide informed written consent Provide informed written consent Provide informed written consent Patients must provide informed consent Patients must provide verbal and written informed consent to participate in the study Patients must provide written informed consent prior to any registration on study Provide informed written consent Provide written informed consent Provide informed written consent Provide written informed consent (Screen 1 and Screen 2) Provide informed written consent Provide informed written consent Patients must provide informed written consent Provide informed written consent Patients who provide written informed consent for participation in this trial Provide informed written consent Provide written informed consent Provide informed consent Provide written informed consent Patients must provide written informed consent Provide informed written consent Patients must provide informed consent Provide informed written consent Willingness to provide written informed consent for the study. Provide written informed consent. Provide informed written consent Patients must provide written informed consent. Provide informed written consent Provide written informed consent Provide informed written consent Provide informed written consent Provide informed written consent Provide written informed consent Provide informed written consent Patients must provide written informed consent Provide informed written consent Provide informed written consent Provide written informed consent Provide informed written consent Both must provide informed consent Provide written informed consent Must provide written informed consent Provide written informed consent Provide written informed consent Provide written informed consent prior to screening Can provide informed consent Provide informed written consent Provide informed written consent Provide informed written consent Patients must provide written informed consent to participate in the study Provide informed written consent Provide informed consent Patients can provide informed consent Willingness to provide written informed consent Provide written informed consent. Provide written informed consent for the study Cannot provide written informed consent Cannot provide written informed consent Provide informed written consent if >= 18 years; if < 18 years, provide informed written assent and parent or legal guardian provide informed written consent Provide written informed consent Patients must provide written informed consent Cannot provide written informed consent Provide informed written consent Patients must provide informed written consent Patients must provide written informed consent Cannot provide written informed consent Provide informed written consent Can provide informed consent Participants must voluntarily agree to provide written informed consent.