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When Dr. Monnett was suspended, the bureau halted the study.
With FDA approval, Johnson & Johnson halted the study, never finding evidence of clear dangers.
Then, in July, investigators for the Women's Health Initiative said they had halted the study because the hormones were conferring health risks -- slightly more heart attacks, strokes, blood clots and breast cancer.
The researchers halted the study after finding a higher risk of breast cancer in women who were taking the drugs compared with those who were taking a dummy pill.
The researchers halted the study prematurely when the accumulating data indicated that even though hormone therapy can reduce cholesterol levels, women who took Prempro had slightly more heart attacks, strokes and blood clots.
Researchers halted the study to assess Aranesp's potential as a treatment for head and neck cancer in October after concluding that it probably would not have a positive outcome.
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Because the advantage of letrozole on disease-free survival was apparent early on, the researchers had to halt the study.
By halting the study in midstream, the researchers made the new treatment available to the placebo group and to many thousands of other cancer survivors as well.
Results are expected within three years, although a safety monitoring board will examine preliminary results this summer and could halt the study if the data suggest that the drug is highly effective.
Zoon said that at least two earlier volunteers who received lower doses than Gelsinger's suffered "Grade 3" liver damage, which required that researchers immediately halt the study and notify the FDA for a decision on whether they could proceed.
The results were so strong, in fact, explains NSABP biostatistician Joseph Constantino, that the independent experts monitoring the data voted on 24 March to halt the study.
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