Edwards, D. (1999) On Model Prespecification in Confirmatory Randomized Studies. Statistics in Medicine, 18, 771-785. http://dx.doi.org/10.1002/(SICI)1097-0258(19990415)18:7<771::AID-SIM80>3.0.CO;2-E

has been cited by the following article:

• TITLE: Racecadotril in the Treatment of Acute Diarrhoea in Adults. An Individual Patient Data Based Meta-Analysis

  AUTHORS: Benoît Coffin, Habib Hamza, Jean-Marie Vetel, Philippe Lehert

  KEYWORDS: Acute Diarrhoea, Racecadotril, Meta-Analysis

  JOURNAL NAME: International Journal of Clinical Medicine, Vol.5 No.7, April 10, 2014

  ABSTRACT: Racecadotril is an antidiarrhoeal drug with a pure intestinal antisecretory mechanism of action. Aim: To assess racecadotril efficacy, whatever its dose, versus placebo in adult acute diarrhoea. Methods: Individual Patient Data meta-analysis following multilevel mixed models testing of the significance of the treatment effect adjusted for baseline covariates. Diarrhoea duration was the common main criteria. Results: Four randomized clinical trials (n = 669) were identified with raw data. The clinical global impression evaluated at baseline by the physician was found to be the essential predictor influencing the outcome. As compared to placebo, the 100 mg dose, the minimum effective dose, induced a 80% increase of the recovered patient proportion at anytime (Hazard Ratio = 1.8 [1.3, 2.5], p i.e. recovery within 3 days (p p .