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 . 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).