Table 5.

Overview of treatment-emergent adverse events related to treatment or study procedures

	Study group	Control group
Serious adverse events related to treatment	0 (0 of 25)	0 (0 of 29)
Adverse events related to treatment	4 (1 of 25)	14 (4 of 29)
Adverse events related to other study procedures	24 (8 of 34)	40 (12 of 30)
Adverse events related to BM or sham aspiration	15 (5 of 34)	7 (2 of 30)

Data are presented as % (n of n). Study group: patients treated with core decompression and implantation of autologous osteoblastic cells. Control group: patients treated with core decompression and placebo implantation. Data are reported for the safety set (all treated patients [n = 54]) or extended safety set (all patients undergoing harvesting [n = 64]). BM = bone marrow.