TABLE III.

Study Cohort: Regular End of Study and Dropouts Until Week 26^*

	Autologous Iliac Bone-Graft Group† (N = 68)	CBVF Group† (N = 65)	Not Randomized† (N = 2)	Total† (N = 135)
Written consent available	68 (100.0%)	65 (100.0%)	2 (100.0%)	135 (100.0%)
Safety population	62 (91.2%)	62 (95.4%)	0 (0.0%)	124 (91.9%)
Intention-to-treat population	68 (100.0%)	65 (100.0%)	0 (0.0%)	133 (98.5%)
Modified intention-to-treat population	52 (76.5%)	56 (86.2%)	0 (0.0%)	108 (80.0%)
Per-protocol population	47 (69.1%)	48 (73.8%)	0 (0.0%)	95 (70.4%)
No. of patients with major protocol violations	5 (7.4%)	8 (12.3%)	0 (0.0%)	13 (9.6%)
No. of patients with study termination	14 (20.6%)	7 (10.8%)	2 (100.0%)	23 (17.0%)
Total no. of major protocol violations‡	24 (100.0%)	19 (100.0%)	0 (0.0%)	43 (100.0%)
Violation of inclusion criteria	3 (12.5%)	5 (26.3%)	0 (0.0%)	8 (18.6%)
Meeting any exclusion criteria	3 (12.5%)	3 (15.8%)	0 (0.0%)	6 (14.0%)
Time interval between visit 2 (day 0, surgery) and visit 7 (week 26) is not 23 to 29 weeks§	18 (75.0%)	11 (57.9%)	0 (0.0%)	29 (67.4%)
Regular end of study	54 (79.4%)	58 (89.2%)	0 (0.0%)	112 (83.0%)
Reasons for study termination‡
Withdrawal of informed consent	1 (6.7%)	1 (11.1%)	0 (0.0%)	2 (7.7%)
Poor compliance	1 (6.7%)	1 (11.1%)	0 (0.0%)	2 (7.7%)
Lost to follow-up	7 (50.0%)	4 (44.4%)	0 (0.0%)	11 (42.3%)
Other interfering therapy of the study participant	4 (28.6%)	2 (22.2%)	0 (0.0%)	6 (26.9%)
Screening error	0 (0.0%)	0 (0.0%)	1 (50.0%)	1 (3.8%)
Administrative or regulatory reasons	0 (0.0%)	0 (0.0%)	1 (50.0%)	1 (3.8%)
Other	1 (6.7%)	1 (11.1%)	0 (0.0%)	2 (7.7%)

^*The analysis set was the enrolled population (n = 135).

^†The values are given as the number of patients, with the percentage in parentheses.

^‡There were multiple entries possible for this category.

^§This category included cases in which 1 or both visits did not take place.