Before participating in a study, volunteers must give their informed consent. This document has a dual purpose. First and foremost, it is a tool to convey information to the volunteer about the study, procedures, anticipated benefits, potential hazards and any discomforts that the study may entail.   By signing this document, the volunteer is stating that they understand what is involved and agree to participate in the study.   The informed consent document will also be used to convey any new information about the study or the investigational medication to the volunteer.   A staff member will describe the study to the potential volunteer. Then the volunteer will carefully read the entire document and then meet with a staff member in order to have any and all questions answered. Once the informed consent document is signed, a copy of the signed document will be given to the volunteer.   Also, a volunteer can revoke this informed consent at any time and for any reason. We only ask that: 1.) All of the testing required for exit from the study be performed in order that we have complete data for the trial. 2.) All study medication be returned.