{"groups":[{"description":"Relugolix 120-milligram (mg) tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.","id":"FG000","title":"Relugolix"},{"description":"Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.","id":"FG001","title":"Leuprolide Acetate"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"8"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"6"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"3"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"13"}],"type":"Testosterone Suppression Level Not Met"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Did not Receive Study Drug"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Dosing Interruption (Logistical Reason)"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"624"},{"groupId":"FG001","numSubjects":"310"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"622"},{"groupId":"FG001","numSubjects":"308"}],"comment":"Four participants (2 in each treatment group) were randomized but did not receive study drug.","type":"Received at Least 1 Dose of Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"563"},{"groupId":"FG001","numSubjects":"276"}],"comment":"Completed 48 weeks of treatment.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"61"},{"groupId":"FG001","numSubjects":"34"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"The primary analysis of efficacy and safety included 934 participants. The primary analysis excluded additional participants with metastatic disease and a cohort of participants enrolled in China and Taiwan who will be included in the final analysis of the study (N=200).","recruitmentDetails":"To support registration in China, the study continued to enroll additional nonmetastatic or metastatic participants from China after the final analysis to reach the target enrollment of approximately 90 participants."}