 Ethics This study will be conducted according to US and international standards of Good Clinical Practice FDA regulations for all studies. Applicable government regulations, University of Arkansas for Medical Sciences research policies and procedures will also be followed. This protocol and any amendments will be submitted and approved by the University of Arkansas for Medical Sciences Institutional Review Board IRB to conduct the study. All subjects for this study will be provided a consent form describing this study and providing sufficient information in language suitable for subjects to make an informed decision about their participation in this study. The formal consent of a subject, using the IRB-approved consent form, will be obtained before that subject is submitted to any study procedure. This consent form must be signed by the subject or legally acceptable surrogate, and the investigator-designated research professional obtaining the consent. 