Type of AA-related AE | True AA (n = 38)a Number (%) | Placebo AA (n = 38) Number (%) | Total (n = 76) Number (%) | Causality between AA and AEb |
---|---|---|---|---|
Minor itching | 0 (0.0%) | 2 (5.3%) | 2 (2.6%) | Probable/likely |
Minor discomfort | 2 (5.3%) | 0 (0.0%) | 2 (2.6%) | Probable/likely |
Minor pain | 5 (13.2%) | 0 (0.0%) | 5 (6.6%) | Probable/likely |
Moderate pain | 1 (2.6%) | 0 (0.0%) | 1 (1.3%) | Probable/likely |
Minor to moderate pain | 1 (2.6%) | 0 (0.0%) | 1 (1.3%) | Probable/likely |