 Statistical Analysis Prevalence and incidence rates: We expect to increase the baseline-screened population from 1376 to more than 2500 individuals in the final study. The number of patients we expect to enroll each year will be calculated and the expected number of new prevalence cases using the 9.7 prevalence rate with the preliminary study data will be estimated. In the preliminary study to date 618 patients have had at least one follow-up visit. Including the remaining 700 patients from the preliminary study and assuming a 10 rate for loss to follow up, we will have 6100-7450 patient years of follow up. The expected number of new incidence cases using the 1.3 incidence rate with the preliminary study data will be estimated. 