{"analyses":[{"groupDescription":"Phase II: During Blinded 4 weeks","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0149","statisticalMethod":"Wilcoxon (Mann-Whitney)"},{"groupDescription":"Phase III","groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.412","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3","upperLimit":"7","value":"5.3"},{"groupId":"OG001","lowerLimit":"0.65","upperLimit":"1.92","value":"1.04"},{"comment":"Phase II was not the open label portion of the study","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"title":"Phase II"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.07","upperLimit":"1.80","value":"0.57"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"1.14","value":"0.45"},{"groupId":"OG002","lowerLimit":"0","upperLimit":"1.78","value":"0.48"}]}],"title":"Phase III"}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"22"},{"groupId":"OG002","value":"41"}],"units":"Participants"}],"description":"Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being \"no pain\" and 10 being \"worst possible pain\"). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Rating Scale pain ratings.The scores were averaged during each phase.","dispersionType":"Inter-Quartile Range","groups":[{"description":"Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule\n\nTopical saline: saline applied to the vestibule mucosa will not reverse the local tenderness","id":"OG000","title":"Topical Saline"},{"description":"Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule\n\nTopical saline: saline applied to the vestibule mucosa will not reverse the local tenderness","id":"OG001","title":"Topical Liquid Lidocaine"},{"description":"During Open-label Lidocaine 8 weeks\n\nEach prior arm converted to use of open label lidocaine for 2 further months.","id":"OG002","title":"Open Label"}],"paramType":"MEAN","reportingStatus":"POSTED","timeFrame":"During Phase II (0-4 weeks) and during Phase III (5-12 weeks)","title":"Prevention of Entry Dyspareunia With Non-hormonal Therapy","type":"PRIMARY","unitOfMeasure":"Units on a scale"}