{"groups":[{"description":"Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a low trough (LT) range of 3 to 7 ng/mL","id":"FG000","title":"Everolimus LT Target of 3 to 7 ng/mL"},{"description":"Participants were randomized to receive everolimus dispersible tablets for oral suspension with titration to a high trough (HT) range of 9 to 15 ng/mL","id":"FG001","title":"Everolimus HT Target of 9 to 15 ng/mL"},{"description":"Participants who received placebo dispersible tablets for oral suspension at study start and switched to everolimus in Extension.","id":"FG002","title":"Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"13"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"8"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"14"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Administrative problems"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Did not continue in Ext"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Did not continue in Post-Ext. Phase"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"}],"type":"Patients never switched to everolimus"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"117"},{"groupId":"FG001","numSubjects":"130"},{"comment":"Of the 119 patients initially randomized to the Placebo arm, 5 patients never switched to everolimus","groupId":"FG002","numSubjects":"119"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"110"},{"groupId":"FG001","numSubjects":"122"},{"groupId":"FG002","numSubjects":"114"}],"type":"Completed Core Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"110"},{"groupId":"FG001","numSubjects":"119"},{"groupId":"FG002","numSubjects":"114"}],"type":"Continued in Ext. Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"79"},{"groupId":"FG001","numSubjects":"92"},{"groupId":"FG002","numSubjects":"81"}],"type":"Completed Ext. Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"90"},{"groupId":"FG002","numSubjects":"81"}],"type":"Continued in Post-Ext. Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"74"},{"groupId":"FG001","numSubjects":"85"},{"groupId":"FG002","numSubjects":"75"}],"type":"Completed Post-Ext Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Did Not Continue in Ext Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Did Not Cont. in Post-Ext Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"74"},{"groupId":"FG001","numSubjects":"85"},{"groupId":"FG002","numSubjects":"75"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"45"},{"groupId":"FG002","numSubjects":"44"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"355 patients were planned to be enrolled and a total of 366 patients were randomized: 117 to the everolimus targeted low-trough arm (LT), 130 to the everolimus targeted high-trough (HT) arm, and 119 to treatment with placebo."}