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Patients in this trial were younger than those in the NSABP tamoxifen P-1 trial and may have been more likely to develop ER (-) tumors, which are unlikely to be reduced in number by tamoxifen therapy .
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In these trials, an increased number of tamoxifen cases of deep vein thrombosis, pulmonary embolus, stroke, and endometrial cancer were observed on the tamoxifen arm compared to the placebo arm .
The frequency of events was consistent with the safety data observed in the NSABP P-1 McCune-Albright Syndrome: A single, uncontrolled multicenter trial of NOLVADEX 20 mg once a day was conducted in a heterogenous group of girls with McCune-Albright Syndrome and precocious puberty manifested by physical signs of pubertal development, episodes of vaginal bleeding and/or advanced bone age (bone age of at least 12 tamoxifen months beyond chronological age) .
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