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The nature and frequency of adverse experiences were similar across all groups.

The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level:

GALLSTONE DISSOLUTION

  Urs odiol Placebo
8-10 mg/kg/day
(N=155)
(N=159)
N (%) N (%)
Body as a Whole
  Allergy 8 (5.2) 7 (4.4)
  Chest Pain 5 (3.2) 10 (6.3)
  Fatigue 7 (4.5) 8 (5.0)
  Infection Viral 30 (19.4) 41 (25.8)
Digestive System
  Abdominal Pain 67 (43.2) 70 (44.0)
  Cholecystitis 8 (5.2) 7 (4.4)
  Constipation 15 (9.7) 14 (8.8)
  Diarrhea 42 (27.1) 34 (21.4)
  Dyspepsia 26 (16.8) 18 (11.3)
  Flatulence 12 (7.7) 12 (7.5)
  Gastrointestinal Disorder 6 (3.9) 8 (5.0)
  Nausea 22 (14.2) 27 (17.0)
  Vomiting 15 (9.7) 11 (6.9)
Musculoskeletal System
  Arthralgia 12 (7.7) 24 (15.1)
  Arthritis 9 (5.8) 4 (2.5)
  Back Pain 11 (7.1) 18 (11.3)
  Myalgia 9 (5.8) 9 (5.7)
Nervous System
  Headache 28 (18.1) 34 (21.4)
  Insomnia 3 (1.9) 8 (5.0)
Respiratory System
  Bronchitis 10 (6.5) 6 (3.8)
  Coughing 11 (7.1) 7 (4.4)
  Pharyngitis 13 (8.4) 5 (3.1)
  Rhinitis 8 (5.2) 11 (6.9)
  Sinusitis 17 (11.0) 18 (11.3)
Upper Respiratory
  Tract Infection 24 (15.5) 21 (13.2)
Urogenital System
  Urinary Tract Infection 10 (6.5) 7 (4.4)

GALLSTONE PREVENTION

  Actigall Placebo
600 mg
(N=322)
(N=325)
N (%) N (%)
Body as a Whole
  Fatigue 25 (7.8) 33 (10.2)
  Infection Viral 29 (9.0) 29 (8.9)
  Influenza-like Symptoms 21 (6.5) 19 (5.8)
Digestive System
  Abdominal Pain 20 (6.2) 39 (12.0)
  Constipation 85 (26.4) 72 (22.2)
  Diarrhea 81 (25.2) 68 (20.9)
  Flatulence 15 (4.7) 24 (7.4)
  Nausea 56 (17.4) 43 (13.2)
  Vomiting 44 (13.7) 44 (13.5)
Musculoskeletal System
  Back Pain 38 (11.8) 21 (6.5)
  Musculoskeletal Pain 19 (5.9) 15 (4.6)
Nervous System
  Dizziness 53 (16.5) 42 (12.9)
  Headache 80 (24.8) 78 (24.0)
Respiratory System
  Pharyngitis 10 (3.1) 19 (5.8)
  Sinusitis 17 (5.3) 18 (5.5)
Upper Respiratory
  Tract Infection 40 (12.4) 35 (10.8)
Skin and Appendages
  Alopecia 17 (5.3) 8 (2.5)
Urogenital System
  Dysmenorrhea 18 (5.6) 19 (5.8)