Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator Ability to provide written informed consent Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator Ability to provide written informed consent Ability to provide written informed consent Ability to give written informed consent Ability to provide written informed consent. Ability to provide written informed consent for the protocol Ability to provide written informed consent Ability to provide written informed consent Ability to provide written informed consent Ability to provide written informed consent Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator Ability to provide written informed consent. Ability to provide written informed consent Ability to provide written informed consent Ability to give written informed consent Ability to provide written, informed consent Ability to provide written informed consent Ability to provide written informed consent Ability to provide written informed consent Ability to provide written informed consent ARM A: Ability to provide informed written consent ARM B: Ability to provide informed written consent Ability to provide written informed consent Ability to give written informed consent Ability to provide written informed consent Willingness and ability to provide written informed consent and to comply with the study protocol as judged by the investigator Ability to provide informed written consent Ability to provide written informed consent and comply with study requirements Ability to provide informed written consent Ability to provide written informed consent Ability and willingness to provide written informed consent Ability and willingness to provide written informed consent Ability to provide informed written consent Ability to provide written informed consent Ability to provide written informed consent Patient must have the ability to give written informed consent Ability to provide written informed consent. Evidence of a personally signed informed consent. Ability to provide informed written consent Ability to provide written informed consent Ability to give written informed consent. Ability to provide written informed consent Have ability to provide full written consent Ability to provide informed written consent Have the ability to give written informed consent Ability to provide informed written consent Ability to provide informed written consent Ability to provide informed written consent Ability to provide informed written consent Ability to provide written informed consent Ability to provide informed written consent Ability to read and provide written informed consent Ability to provide written informed consent Ability to provide written informed consent in accordance with institutional policies Ability to provide written informed consent Ability to provide written, informed consent. Ability and willingness to provide written informed consent