Sample size in the original protocol for this study was calculated as described in section 12.1 below. Because data from a third site of this multicenter trial (Atlanta Northside) will not be used, the total sample size goal (N = 170) in the original protocol will not be reached. Mercy was approved by the IRB in September 2012 to enroll 100 patients total; the Chicago site is approved to enroll 57 patients. Thus, the total sample size goal has been revised to 157; minimal detectable differences under the conditions of 90% power are described in section 12.2 below.