{"groups":[{"description":"Patients received fulvestrant (Faslodex™) 500 milligrams (mg), administered as two 5 milliliters (mL) intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).","id":"FG000","title":"Fulvestrant 500 mg"},{"description":"Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \\[±3\\], 28 \\[±3\\] and every 28 \\[±3\\] days thereafter).","id":"FG001","title":"Anastrozole 1 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"147"},{"groupId":"FG001","numSubjects":"145"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"41"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"12"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}],"type":"Eligibility criteria not fulfilled"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"230"},{"groupId":"FG001","numSubjects":"232"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"31"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"205"},{"groupId":"FG001","numSubjects":"201"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"524 patients were enrolled (signed informed consent). Patients were assigned to treatment if they met all inclusion and none of the exclusion criteria. 62 patients were not randomised, mainly due to eligibility criteria not being fulfilled (44/62 patients) or patient decision (13/62 patients). 462 patients were randomised to receive treatment.","recruitmentDetails":"First patient enrolled: 17 October 2012."}