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The Cochran-Mantel-Haenszel mean score test will be used.
Stool consistency, fussiness, and gas were analyzed using the Cochran-Mantel-Haenszel (CMH) row mean score test.
The global evaluation of study medication was analyzed using modified ridit scores via Cochran Mantel Haenszel row mean score test, controlling for sex and baseline pain severity.
Subject self-assessment was also evaluated using the Cochran Mantel–Haenszel row mean score test with integer scores stratified by site.
The secondary efficacy endpoint was the categorical change in terminal hair density from baseline, analyzed using the Cochran Mantel–Haenszel row mean score test with integer scores stratified by study site.
A comparison of pre- and posttest mean open-ended scores was also made using the mean score test statistic (Q), approximately a chi-square test statistic, of the Cochran Mantel–Haenszel method, as suggested by Stokes et al. (2000).
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For binary variables (e.g., sex, language) Fisher's exact test was used; for ordered categorical variables, the row mean scores test was used.
The change in patients' and investigators' assessment of fatigue and dyspnoea were compared between groups using the Cochran-Mantel-Haenszel row-mean score test.
The effect was statistically dose-dependent (p = 0.03, Cochran Mantel–Haenszel [CMH] row means score test).
The percentage of patients with increased biomicroscopic scores was compared between groups using the Cochrane Mantel–Haenszel row mean-score test.
For ease of interpretation and numerical stability the centered version of the pre-test score, score pre-test – mean score pre-test, was used as independent variable in the regression analysis.
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