{"groups":[{"description":"Part 1 (lead-in) period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed).\n\nFirst apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.","id":"FG000","title":"BL-8040 + G-CSF Part 1"},{"description":"Part 2: randomized, double-blinded, placebo controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 up to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. BL-8040 1.25 mg/kg s.c. on Day 4 (and Day 6, if needed).\n\nFirst apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.","id":"FG001","title":"BL-8040 + G-CSF Part 2"},{"description":"Part 2: randomized, double-blinded, placebo controlled period. G-CSF given one time daily s.c. for 5-8 days (Day 1 to 8) at doses of approximately 10 µg/kg/day but not more than 15 µg/kg/day. Placebo s.c. on Day 4 (and Day 6, if needed).\n\nFirst apheresis on Day 5 with up to 3 additional procedures possible until Day 8, as needed.","id":"FG002","title":"Placebo + G-CSF Part 2"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}],"type":"Other Reasons"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"4"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"80"},{"groupId":"FG002","numSubjects":"42"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"77"},{"groupId":"FG002","numSubjects":"37"}],"type":"Post Transplantation Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"74"},{"groupId":"FG002","numSubjects":"34"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"8"}],"type":"NOT COMPLETED"}],"title":"Core Study (until 100 d post-transplant)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"comment":"One (1) subject early terminated the study following the core study period and before the follow up (FU)","groupId":"FG001","numSubjects":"73"},{"groupId":"FG002","numSubjects":"34"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"66"},{"groupId":"FG002","numSubjects":"32"}],"comment":"Long Term FU is ongoing. Numbers are of the subject ongoing in the study.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Follow-up period at 1 year FU Completion"}],"recruitmentDetails":"A total of 180 subjects signed the Informed Consent Form (ICF) and screened to the study. A total of 136 subjects received at least one dose of G-CSF. A total of 134 subjects were treated with G-CSF and with BL-8040 or Placebo."}