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此研究是在英联邦严格按照美国的临床研究标准进行的。美国食物和药品管理局(FAD)现行要求,临床试验至少要有10000个暴露周期和200个连续暴露13周期的妇女,并须按临床操作规范的标准实施。这次研究约有50个中心参与,试验设计连续暴露26周期,受试者共1221人,有1195例纳入分析,其中46%为受试前2个月未用
This study was conducted in the Commonwealth in strict accordance with the United States clinical research standards. The current requirements of the U.S. Food and Drug Administration (FAD) require clinical trials of at least 10,000 cycles of exposure and 200 women exposed to 13 cycles of continuous exposure and should be conducted in accordance with the standards of clinical practice. Approximately 50 centers participated in this study. The trial design was continuously exposed for 26 cycles. A total of 1221 subjects were enrolled and 1195 were included in the study, 46% of which were unused for 2 months prior to the study