{"analyses":[{"groupDescription":"Change from baseline to week 3","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.28","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupDescription":"Change from baseline to week 12","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.34","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"1.0","value":"0.0"},{"groupId":"OG001","lowerLimit":"-1.0","upperLimit":"2.0","value":"0.0"}]}],"title":"Changes between baseline and week 3"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.0","upperLimit":"2.0","value":"0.0"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"1.0","value":"0.0"}]}],"title":"Changes between baseline and week 12"}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"Change in pruritus or itching from baseline to week 3 and week 12\n\nEach symptom will be scored in a numeric scale from 0 to 3, as shown below:\n\n0 Absence. The symptom is not present\n\n1. The symptom is of mild intensity, without interfering in the patient's activity\n2. The symptom is of moderate intensity, causing obvious discomfort to the patient\n3. The symptom is stated as very irritating and severe in intensity","dispersionType":"Inter-Quartile Range","groups":[{"description":"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration","id":"OG000","title":"0.005% Estriol Vaginal Gel"},{"description":"Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration\n\nPlacebo","id":"OG001","title":"Placebo Vaginal Gel"}],"paramType":"MEDIAN","populationDescription":"postmenopausal women","reportingStatus":"POSTED","timeFrame":"Change from baseline to week 3 and week 12","title":"Change in Pruritus or Itching From Baseline to Week 3 and Week 12","type":"SECONDARY","unitOfMeasure":"units on a scale"}