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Details of each CV event were obtained from the treating physician. The independent end point committee of the active trial period reviewed all end points and the members had no knowledge of the subject's treatment assignments. At trial follow-up visits, various clinical and biochemical measurements were performed and two 24-hour urine collections were obtained. Systolic and diastolic blood pressures were calculated as the mean of the last two of ten consecutive measurements, using an automatic Dinamap XL model 9300 series device (Johnson & Johnson Medical Inc.). Serum creatinine, plasma cholesterol and glucose were determined in one laboratory by Kodak Ektachem dry chemistry (Eastman Kodak, Rochester, selleck inhibitor NY, USA), using an automated enzymatic method. The intra- and interassay bepotastine variation coefficient of serum creatinine were respectively 0.9% and 1.1%. Serum triglycerides were measured enzymatically. A commercially available assay system was used to assess high-density lipoprotein (HDL) cholesterol (Abbott Inc., Abbott Park, IL, USA). Urinary albumin concentrations were determined by nephelometry with a threshold of 2.3?mg/L and intra-assay and interassay coefficients of variation of less than 2.2% and 2.6%, respectively (Dade Behring Diagnostic). 10-year risk for CV events according to the FRS was calculated as described by D'Agostino [14] and divided into three risk categories: low (?20%), as recommended by Wilson [16]. UAE was categorized by low (Y-27632 chemical structure showed a log-linear functional shape with the response variable and were transformed to a 2-log scale and reported as median (interquartile range). This means that risk estimates should be interpreted as the relative risk of values were doubled (e.g. 1 to 2?mg/L or 10 to 20?mg/24?h). Times to first occurrence of outcomes are presented as Kaplan�CMeier estimates, and statistical differences between placebo and active treatments were analyzed by log-rank testing. To assess the additive value of UAE over the FRS, we evaluated the Integrated Discrimination Improvement (IDI) and Net Reclassification Improvement (NRI) indices for UAE (both as a continuous variable as well as dichotomized to high vs. low, using a cut-off of 50?mg/24?h) according to FRS. All reported probability values are two-tailed and P?