{"groups":[{"description":"Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.","id":"FG000","title":"Canakinumab, Pre-filled Syringes (PFS)"},{"description":"The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.","id":"FG001","title":"Canakinumab, Lyophilizate (LYO)"},{"description":"The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.","id":"FG002","title":"Triamcinolone Acetonide"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}],"type":"Protocol Deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"5"}],"type":"Administrative Problems"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"6"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"7"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"4"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}],"type":"Adverse Event"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"133"},{"groupId":"FG001","numSubjects":"132"},{"groupId":"FG002","numSubjects":"132"}],"type":"STARTED"},{"achievements":[{"comment":"In this arm, 1 patient had only 3 placebo injections and 3 patients also took other active drug.","groupId":"FG000","numSubjects":"133"},{"comment":"In this arm, 3 patients also took other active drug.","groupId":"FG001","numSubjects":"133"},{"comment":"In this arm, 3 patients also took other active drug.","groupId":"FG002","numSubjects":"133"}],"type":"Safety Set"},{"achievements":[{"groupId":"FG000","numSubjects":"131"},{"groupId":"FG001","numSubjects":"129"},{"groupId":"FG002","numSubjects":"129"}],"type":"Full Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"124"},{"groupId":"FG001","numSubjects":"117"},{"groupId":"FG002","numSubjects":"108"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"24"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Number of subjects randomized was 397. Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to a safety set of 399 subjects. Subjects who did not receive study drug were excluded from analysis."}