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Nevertheless, in the pooled analysis of the Phase 3 echocardiographic data,botanical gardens fort wayne, the relative risk for FDA defined valvular heart disease (VHD), defined as mitral regurgitation greater than mild or aortic regurgitation greater than trace was 1.16, with a 95% confidence interval (CI) of 0.81 to 1.67. This upper bound exceeds the 1.5 upper bound requested by FDA to rule out an excess risk of VHD. The point estimate and upper bound were similar in a number of sensitivity analyses conducted by the sponsor and FDA statistician.