Patients randomized | 105 (100) | 108 (100) | 110 (100) |
Patients who received treatment | 105 (100) | 108 (100) | 109 (99.1) |
Patients who did not receive treatment for severe noncompliance to protocol | 0 (0) | 0 (0) | 1 (0.9) |
Patients who discontinued treatment | 38 (36.2) | 43 (39.8) | 54 (49.1) |
Adverse event | 8 (7.6) | 10 (9.3) | 10 (9.1) |
Study-specific criteriaa | 2 (1.9) | 1 (0.9) | 0 (0.0) |
Nonresponse at Week 12b | 18 (17.1) | 21 (19.4) | 35 (31.8) |
Lack of therapeutic response | 0 (0.0) | 7 (6.5) | 4 (3.6) |
Severe noncompliance to protocol | 2 (1.9) | 1 (0.9) | 2 (1.8) |
Subject decision | 1 (1.0) | 0 (0.0) | 0 (0.0) |
Subject lost to followup | 0 (0.0) | 0 (0.0) | 1 (0.9) |
Other | 7 (6.7) | 3 (2.8) | 2 (1.8) |
Patients who completed study | 67 (63.8) | 65 (60.2) | 55 (50.0) |