Table 3
Primary outcome
Initial study
Current study
P value
Failure
Stage 1
3 (6%)
0
0.02
Stage 2
1 (2%)
1 (2%)
1
Stage 3a
1 (2%)
0
1
Stage 3b
1 (2%)
0
1
Crossover
4 (8%)
1 (2%)
0.16
Termination
2 (4%)
0
0.11
Success
44 (88%)
49 (98%)
0.05