Interested participants are first screened for eligibility to enter the clinical trial.  Medical histories will be reviewed by either the study physician or a study nurse. Once a preliminary determination is made of possible eligibility, interested participants are provided a detailed description of the experimental protocol, information about the study drug, and information about what's expected of volunteers in the study, including the schedule of appointments and procedures, information on financial responsibility, the length of the study and answering of all questions.  This information will be outlined in an informed consent form which will be provided prior to enrollment in the study for review.  The volunteers' health will continue to be monitored during and after the trial.