Further corroboration with a pathology assessment using 10G-Semmes-Weinstein monofilament in one of more of the 6 plane areas evaluated.- Also considered as a complication are those deaths related to cardiovascular disease e.g. myocardial infarction that causes death.g) Determination of sample sizeWith an ?? risk of 0.05 for a precision of ?? 3% in a two-tailed test of difference in proportions of