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Table 9 Number (%) of patients with the most commonly reported system organ classes in the treatment and extension periods, safety population.

From: Nightly treatment of primary insomnia with prolonged release melatonin for 6 months: a randomized placebo controlled trial on age and endogenous melatonin as predictors of efficacy and safety

System organ class Treatment period Extension period
  PRM(n= 394) Placebo(n= 395) PRM(n= 534) Placebo(n= 177)
Infections and infestations 38 (9.6) 43 (10.9) 176 (33.0) 60 (33.9)
Gastrointestinal disorders 18 (4.6) 31 (7.8) 113 (21.2) 37 (20.9)
Musculoskeletal and connective tissue disorders 21 (5.3) 21 (5.3) 113 (21.2) 34 (19.2)
Nervous system disorders 19 (4.8) 23 (5.8) 47 (8.8) 19 (10.7)
Respiratory, thoracic and mediastinal disorders 12 (3.0) 16 (4.1) 47 (8.8) 18 (10.2)
Skin and subcutaneous tissue disorders 12 (3.0) 9 (2.3) 43 (8.1) 13 (7.3)
Injury, poisoning and procedural complications 8 (2.0) 2 (0.5) 35 (6.6) 13 (7.3)
Renal and urinary disorders 9 (2.3) 4 (1.0) 29 (5.4) 7 (4.0)
General disorders and administration site disorders 5 (1.3) 5 (1.3) 28 (5.2) 16 (9.0)
Investigations 5 (1.3) 7 (1.8) 24 (4.5) 9 (5.1)
Eye disorders 5 (1.3) 1 (0.3) 20 (3.7) 6 (3.4)
Psychiatric disorders 5 (1.3) 4 (1.0) 17 (3.2) 13 (7.3)
Vascular disorders 2 (0.5) 0 (0) 16 (3.0) 5 (2.8)
Cardiac disorders 0 (0) 1 (0.3) 15 (2.8) 2 (1.1)
Ear and labyrinth disorders 0 (0) 1 (0.3) 13 (2.4) 2 (1.1)
Reproductive system and breast disorders 3 (0.8) 3 (0.8) 12 (2.2) 1 (0.6)
Metabolism and nutrition disorders 1 (0.3) 2 (0.5) 7 (1.3) 4 (2.3)
Surgical and medical procedures 1 (0.3) 2 (0.5) 7 (1.3) 6 (3.4)
  1. PRM, prolonged release melatonin.