{"description":"All patients that started treatment and were assessed for adverse events were included in this section. This includes all 147 patients from Arm I, 148 patients from Arm II (one patient was not assessed for Adverse Events), and 147 patients from Arm III. In addition, patients from Arm III: Placebo were given the opportunity to receive treatment according to the Arm II: High Dose schedule upon completion of 12 weeks. 94 of the 147 patients randomized to Arm III opted to continue treatment.","eventGroups":[{"description":"Participants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \\[DHEA\\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.","id":"EG000","otherNumAffected":91,"otherNumAtRisk":147,"seriousNumAffected":3,"seriousNumAtRisk":147,"title":"Arm I: Low Dose DHEA"},{"description":"Participants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.","id":"EG001","otherNumAffected":105,"otherNumAtRisk":148,"seriousNumAffected":7,"seriousNumAtRisk":148,"title":"Arm II: High Dose DHEA"},{"description":"Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.\n\nThere is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.","id":"EG002","otherNumAffected":93,"otherNumAtRisk":147,"seriousNumAffected":4,"seriousNumAtRisk":147,"title":"Arm III: Placebo"},{"description":"Patients randomized to Arm III Placebo who have completed protocol treatment for 12 weeks were offered the option of continuing treatment according to Arm II High Dose DHEA until unacceptable adverse events or patient refusal to continue participation on the study.\n\n94 of the 147 patients randomized to the Placebo arm opted to continue treatment with High Dose DHEA.","id":"EG003","otherNumAffected":28,"otherNumAtRisk":94,"seriousNumAffected":0,"seriousNumAtRisk":94,"title":"Optional Continuation Phase"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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