Exposure to an investigational product is associated with some risk. Your body may respond in an unexpected way to the investigational product, you may not receive the intended benefit, or you may experience unexpected or unwanted side effects. However, both the U.S. Food and Drug Administration and the Institutional Review Boards monitor research studies closely. Studies that are deemed unsafe or unethical by the Institutional Review Board are not conducted. Your study coordinator and physician also closely monitor your health status and response to the study drug throughout study participation. At your first study visit all of the risks and benefits are outlined in a very detailed document called the Informed Consent Form. This form is reviewed and the study patients can discuss any questions with the study coordinator and doctor prior to any study procedures being conducted.