Written informed consent and authorization for release of personal health information obtained according to local laws. Written authorization for use and release of health and research study information has been obtained. Written authorization for use and release of health and research study information has been obtained Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information Able and willing to provide written authorization for use and release of health and research study information Written informed consent and authorization for release of personal health information obtained according to local laws. Provided written authorization for use and release of health and research study information. Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information Written authorization for use and release of health and research study information has been obtained Written authorization for use and release of health and research study information (United States [US] sites only) has been obtained Written Authorization for Use and Release of Health and Research Study Information (United States [US] sites only) has been obtained Written Authorization for Use and Release of Health and Research Study Information has been obtained Informed consent and authorization for the release of health information signed by the patient Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information Written authorization for use and release of health and research study information has been obtained Written authorization for use and release of health and research study information has been obtained Written authorization for use and release of health and research study information has been obtained Able to provide written informed consent and authorization for release of health information Signed HIPAA compliant research authorization (or equivalent for international sites) to release Personal Health Information to the SunCoast CCOP Research Base must be obtained prior to registration Written authorization for use and release of health and research study information has been obtained Written informed consent and authorization to use and disclose health information Subject consent and authorization for the release of health information must be obtained according to local institutional guidelines