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[求助]
药理学翻译
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求大牛帮翻译，要专业一些 1. Subjects with confirmed down-regulation of FSH (≤ 5 IU/L) and oestradiol (≤ 50 pg/ml), measured on Day -3 and on Day -1, who continue to meet the eligibility criteria (assessed on Day 1) will receive treatment with one of three YYY doses (150 IU, 300 IU, or 450 IU) in the single-dose part of the study or the 150 IU dose in the multiple-dose part. Doses in the single-dose part will be studied in sequence, starting with the lowest dose and finishing with the highest dose. The multiple-dose part will be conducted in parallel with the single-dose part. 2. 9.1 Determination of Sample Size No formal sample size calculations have been performed for this trial. However, 8 subjects per group and dose level who complete the study and are eligible for inclusion in the PP analysis set are considered sufficient to provide adequate information on the PK of XXX. The Intention-to-treat (ITT) analysis set will comprise data from all XXX treatment assigned subjects. The ITT analysis set will be used for presentation of subject disposition. |
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2楼2015-01-19 15:39:04
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