{"groups":[{"description":"In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.","id":"FG000","title":"Fentanyl Sublingual Spray - Titration"},{"description":"Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.","id":"FG001","title":"Fentanyl Sublingual Spray - Double-blind"},{"description":"Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.","id":"FG002","title":"Placebo - Double-blind"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"130"},{"comment":"There were no participants in this reporting group in the titration period.","groupId":"FG001","numSubjects":"0"},{"comment":"There were no participants in this reporting group in the titration period.","groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"98"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Titration Period"},{"milestones":[{"achievements":[{"comment":"There were no participants in this reporting group in the double-blind period.","groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"98"},{"comment":"There were no participants in this reporting group in the double-blind period.","groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"95"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Fentanyl Sublingual Spray - Double-blind"},{"milestones":[{"achievements":[{"comment":"There were no participants in this reporting group in the double-blind period.","groupId":"FG000","numSubjects":"0"},{"comment":"There were no participants in this reporting group in the double-blind period.","groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"98"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"95"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"}],"type":"NOT COMPLETED"}],"title":"Placebo - Double-blind"}],"preAssignmentDetails":"As there are dozens, if not hundreds, of cross-over sequences during the double-blind period of this study, instead of reporting participant flow for each of the cross-over sequences, participant flow is reported separately for the fentanyl and placebo groups."}