{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"164"},{"groupId":"OG001","value":"169"},{"groupId":"OG002","value":"84"}],"units":"Participants"}],"description":"Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows:\n\n1. The original discharge characteristic of bacterial vaginosis has returned to a normal physiological vaginal discharge which varies in appearance and consistency depending on the menstrual cycle,\n2. The whiff test is negative for any amine (\"fishy\") odor,\n3. The saline wet mount is negative for clue cells,\n4. Vaginal fluid pH is \\< 4.7, using pH paper that measures from 3.6 to 6.1.\n\nA Bacteriological cure is defined as a Nugent score \\< 4.\n\nThe system used a 0-4 scale (Nugent Scoring System 0-10 for Gram-Stained Vaginal Smears) for evaluation of vaginal flora, based on the weighted sum of the following 3 bacterial morphotypes scores calculated from slide examination under oil immersion field:\n\n1. Lactobacillus: large gram positive rods,\n2. Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods,\n3. Mobiluncus spp.: thin, curved Gram variable rods","groups":[{"description":"One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.)\n\nclindamycin phosphate vaginal cream 2%","id":"OG000","title":"Test Product"},{"description":"One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing approximately 100 mg of Clindesse® (clindamycin phosphate vaginal cream 2% ) (Ther-Rx™)\n\nclindamycin phosphate vaginal cream 2%","id":"OG001","title":"Reference Product"},{"description":"One single-dose, pre-filled disposable applicator delivering approximately 5 g of cream containing vehicle of the test product (Watson Laboratories, Inc.)\n\nplacebo: vehicle used as placebo","id":"OG002","title":"Placebo"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"22 to 30 days","title":"Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score <4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30).","type":"PRIMARY","unitOfMeasure":"Participants"}