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​英訳サンプル:       7​

All subjects will be initially identified by a panelist screening number.  Once the subject meets qualification criteria, a permanent subject number will be assigned at the baseline visit.  This permanent subject number will be assigned in sequence as subjects are enrolled into the study.  The treatment randomization sequence will correspond to the permanent subject number assigned.  A master roster will be kept of the panelist screening number and the corresponding permanent subject number for each subject.

Prior to study enrollment, potential subjects will be questioned regarding their medical history and any medications taken 2 weeks prior to study initiation.  This information will be recorded by the study site staff on the Medical History and Concomitant Medication Forms.  Inclusion/exclusion information will be collected and recorded on the Subject Inclusion/Exclusion Form. The information will be reviewed by the site staff to determine qualification of the subject for study enrollment.

Each subject will be given a urine pregnancy test.  Subjects with negative pregnancy test results will be examined for qualification.  An examination of external genitalia, as well as an internal speculum examination for signs of erythema, edema and any vulvar, cervical, or perineal inflammation or irritation will be performed.  Vaginal discharge will also be assessed and graded as normal or abnormal. Examination observations will be graded according to the scoring scales listed in Section 8.0, and the results will be recorded on the appropriate case report form.   Qualified subjects will be instructed to return to the laboratory 6 days (± 1 day) prior to the expected onset of menses.

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