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Table 3 Effects of 3 weeks treatment with prolonged release melatonin (PRM) and placebo on sleep diary-recorded sleep latency in the low excretors and the elderly patients.

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

  Treatment Treatment effect difference PRM - placebo; (95% confidence interval) Pvalue* effect PRM versus placebo
  PRM Placebo   
Low excretor population     
N 86 86   
Baseline: mean (SD) 74.1 (54.9) 75.5 (58.5)   
Treatment: mean (SD) 65.1 (59.9) 66.5 (51.6)   
Change from baseline: mean (SD) -9.0 (50.5) -9.0 (48.7) -0.6 (-14.0, 12.7) 0.924
65-80 year population     
N 137 144   
Baseline: mean (SD) 76.7 (63.7) 72.5 (51.4)   
Treatment: mean (SD) 57.6 (51.8) 70.9 (54.0)   
Change from baseline: mean (SD) -19.1 (47.3) -1.7 (47.8) -15.6 (-25.3, -6.0), 0.002
  1. *Linear regression model with terms for treatment (PRM versus placebo), baseline sleep latency and age group (≥65 or <65 - only for the low excretors).
  2. PRM, prolonged release melatonin; SD, standard deviation.