Research Design and Methods Visit 1 Subjects who sign the informed consent and medical history forms and meet the preliminary entrance criteria will be examined at baseline. All participants will be informed of the nature of the study, its purpose, and any possible risks. Subjects will also be informed as to the length of the study and the specific procedures that will be carried out. Subjects will be informed that this is a voluntary study and that they are free to withdraw from the study at any time.