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A second McNeil letter posted this week on the F.D.A. Web site said the company had assessed stability testing of all products made at the Las Piedras plant and planned to begin better analysis methods, where appropriate, by the end of this year.

Correlations or differences between groups were tested statistically using parametric or nonparametric methods where appropriate.

Safety outcomes will be reported as unadjusted patient proportions and rates within and between arms with 95% CIs using exact methods where appropriate.

Bivariate analyses, including chi-square tests, Fisher's exact tests, Student T-tests or ANOVA methods, where appropriate, were used in a first step.

Pregnant/nursing women, those using insufficient birth control methods (where appropriate), or any patient who had an uncontrolled or intercurrent illness that would limit compliance with study requirements or effect the interpretation of the results were excluded.

Similar(55)

Post-ANOVA comparisons among means were made using the Holm-Sidak method where appropriate.

Multiple comparisons were controlled by the Bonferroni method where appropriate.

Effectiveness data were presented as changes from baseline, missing values were imputed by the LOCF-method, where appropriate.

We specified a maximum intron size of 5,000 bp and strand-specific reads prepared using the dUTP method where appropriate.

Data were tested for normality using the Kolmogorov-Smirnov test with Dallal and Wilkonson approximation of the Lillifores method, where appropriate.

Pearson correlation coefficients and tests for correlation between paired samples were computed using the statistical software R. P-values were corrected for multiple testing using the Bonferroni method where appropriate.

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