{"groups":[{"description":"Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.","id":"FG000","title":"Dexamethasone Based Mouthwash"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"14"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"New cancer therapy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Administrative problems"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Abnormal laboratory values"},{"reasons":[{"groupId":"FG000","numSubjects":"10"}],"type":"Adverse Event"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"86"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"50"}],"type":"Pharmacokinetic Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"56"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"30"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"A total of 92 participants were enrolled into the study and received study treatments of everolimus and exemestane. Of these, 86 participants were confirmed to have also received the investigational treatment of dexamethasone steroid mouthwash and comprised the full analysis set (FAS). The patient disposition is based on the FAS."}