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In the course of Merck's progress to post the results of clinical studies to the public website http://www.clinicalstudyresults.org (in compliance with guidelines under the US Food and Drug Administration Amendments Act [FDAAA]), a review of clinical trial data to be included in posting synopses uncovered a discrepancy between the clinical study report for montelukast Protocol 162 and the manuscript published in Clin Exp Allergy [1]. Specifically, we noticed the following discrepancy:

In Table 1, the numbers for patient gender are reversed. The correct values are:

Placebo: M=123; F=229

Montelukast: M=115; F=233

Loratadine: M=212; F=390

George Philip (on behalf of the authors of this manuscript).

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  • 1
    Philip G, Malmstrom K, Hampel Jr FC et al. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring. Clin Exp Allergy 2002; 32:10208.