{"groups":[{"description":"Participants received oral dose of everolimus 4.5 milligram/square meter (mg/m\\^2) daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 nanogram/millilitre (ng/mL). Dose adjustments were permitted based on safety and whole blood trough concentrations.","id":"FG000","title":"Everolimus"},{"description":"Participants received oral dose of placebo matching to everolimus daily.","id":"FG001","title":"Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Administrative problems"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"39"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"33"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"6"}],"type":"NOT COMPLETED"}],"title":"Core Period (48 Weeks)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"0"}],"type":"Administrative problems"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"New treatment for indication under study"}],"milestones":[{"achievements":[{"comment":"Of 117 participants only 111 completed the core period and continued in the extension period","groupId":"FG000","numSubjects":"111"},{"comment":"No participant received placebo.","groupId":"FG001","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"82"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Open-label Extension Period (4 Years)"}],"preAssignmentDetails":"A total of 117 participants were enrolled and randomized into the core period. Only 111 participants completing the core period, continued in the open-label extension period of the study.","recruitmentDetails":"The study was conducted at 24 centers in 10 countries."}