Patients who have circumstances that will not permit completion of this study or the required follow-upXx_NEWLINE_xXPatients whose circumstances do not permit completion of the study or the required follow-upXx_NEWLINE_xXParticipants with circumstances that will not permit completion of the study or required follow-up; for instance, if travel to and from treatment site is an issueXx_NEWLINE_xXPatients with circumstances that will not permit completion of the study or the required follow-upXx_NEWLINE_xX