40 mg (N=9) 40 mg (N=9) 80 mg (N=8) 80 mg (N=8) Placebo (N=6) Placebo (N=6)
n (%) m n (%) m n (%) m
Infections and infestations 3 (33.3%) 3 2 (25.0%) 2 0 0
  Nasopharyngitis 3 (33.3%) 3 2 (25.0%) 2 0 0
Respiratory, thoracic and mediastinal disorders 1 (11.1%) 1 3 (37.5%) 3 1 (16.7%) 1
  Nasal congestion 0 0 2 (25.0%) 2 1 (16.7%) 1
  Epistaxis 0 0 1 (12.5%) 1 0 0
  Oropharyngeal pain 1 (11.1%) 1 0 0 0 0
Nervous system disorders 0 0 4 (50.0%) 17 0 0
  Somnolence 0 0 2 (25.0%) 8 0 0
  Disturbance in attention 0 0 1 (12.5%) 7 0 0
  Headache 0 0 1 (12.5%) 1 0 0
  Tremor 0 0 1 (12.5%) 1 0 0
General disorders and administration site conditions 0 0 1 (12.5%) 1 0 0
  Fatigue 0 0 1 (12.5%) 1 0 0
Musculoskeletal and connective tissue disorders 1 (11.1%) 2 0 0 0 0
  Musculoskeletal pain 1 (11.1%) 1 0 0 0 0
  Pain in extremity 1 (11.1%) 1 0 0 0 0