Subject has given written informed consent Patient must have given written informed consent Has read and understands the informed consent form and has given written informed consent prior to any study procedures The patient has given written informed consent after the nature of the study and alternative treatment options have been explained Subjects given written informed consent Has given written consent to participate in the study. Written informed consent is given Patient has given written informed consent. Written informed consent is given Subjects given written informed consent Subjects given written informed consent Unwillingness or inability to given written informed consent. Has read and understands the informed consent form and has given written informed consent prior to any study procedures. Written informed consent is given Have given written informed consent prior to any study procedures Has given written Informed Consent Has given written informed consent. patient had given written informed consent. Has the subject given written informed consent? Capable of given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Subjects must have given written informed consent to agree to participate Subjects must have given written informed consent Subjects given written informed consent. Patient has been informed of the investigational nature of this study and has given written Informed Consent and is able to adhere to dosing and visit schedules and meet all study requirements Given written informed consent (patient and donor) Subjects unwilling or unable to given written informed consent