TABLE II.
Dose 1
|
Dose 2
|
Dose 3
|
Dose 4
|
Dose 5
|
Dose 6
|
||||
---|---|---|---|---|---|---|---|---|---|
Pre (N =24) | 5 min post (N =22) | 48 hr post (N =19) | 48 hr post (N =23) | 72 hr post (N =21) | 5 min post (N =21) | 48 hr post (N =22) | 48 hr post (N =24) | 72 hr post (N =21) | |
Mean (IU/ml) ±SD | 12.65 ± 3.16 | 0.37 ± 0.28 | 0.42 ± 0.36 | 0.088 ± 0.095 | 12.10 ± 3.11 | 0.32 ± 0.24 | 0.32 ± 0.23 | 0.089 ± 0.072 | |
% Patients ≥0.05 IU/ml |
0 | 100 | 100 | 100 | 52 | 100 | 95 | 92 | 52 |
% Patients ≥0.10 IU/ml |
0 | 100 | 89 | 91 | 38 | 100 | 82 | 83a | 43b |
% Patients ≥0.4 IU/ml |
0 | 100 | 32 | 43 | 0 | 100 | 36 | 29 | 0 |
Primary end-point.
Secondary end-point.