Using basic science to design a clinical trial: baseline characteristics of women enrolled in the Kronos Early Estrogen Prevention Study (KEEPS).

While these criteria were believed to be sufficient at the time of the trial, many subjects had significant CVD risk and/or were found to have had a prior CVD [ 35 , 71 ].The CEE+MPA portion of the WHI trial was stopped early in 2002 because accumulating data showed a trend toward increased breast cancer which crossed a prespecified stopping point; thus, the benefit/risk ratio for the treatment was believed to have shifted from positive to negative [ 71 ].

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