| Screening | Preparation for operation | Operation | Observation period | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Registration and assignment | †Blood sampling | †Bone marrow sampling | Preoperative examination | Day − 1 | Day 0 | Day 1 | Month 1 | Month 3 | Month 6 | Month 12 | Month 24 | |
Eligibility criteria | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Vital signs‡ |  | X |  | X |  | X | X | X |  |  |  |  |
Laboratory tests | ||||||||||||
 Infections§, HbA1c | X |  |  |  |  |  |  |  |  |  |  |  |
 Hematology¶, Biochemistry††, CRP, Coagulation‡‡ | X | X§§ |  | X |  |  | X | X | X | X | X | X |
 Urinalysis¶¶ |  |  |  | X |  |  | X | X | X | X | X | X |
 Blood sampling |  | X |  |  | X |  |  |  |  |  |  |  |
 Bone marrow sampling |  |  | X |  |  |  |  |  |  |  |  |  |
 Panoramic X-ray | X |  |  |  |  |  | X | X | X | X | X | X |
 Facial CT | X |  |  |  |  |  | X | X | X | X | X | X |
 Tooth mobility†††| X |  |  |  |  |  |  |  | X | X | X | X |
 Masticatory force | X |  |  |  |  |  |  | X | X | X | X | X |
 Biopsy of bone (if needed) for histology |  |  |  |  |  |  |  | X | X | X | X | X |
 Transplantation of tissue engineered materials |  |  |  |  |  | X |  |  |  |  |  |  |
 Concomitant therapies | X | X | X | X | X | X | X | X | X | X | X | X |
 Adverse events |  | X | X | X | X | X | X | X | X | X | X | X |