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The effect of the random factor "ozone" in combination with fixed factors "site" and "time" on the response variables was therefore formally investigated using the ANCOVA model.
Secondary (ADCS ADL19) and additional efficacy parameters (NPI, VFT) were analyzed using the ANCOVA model.
The analysis was done using the ANCOVA model including treatment and baseline as covariate.
Equivalence of XM02 and Neupogen™ was assessed based on the PP set, using the ANCOVA model to calculate a 2-sided 95% CI for "XM02 minus Neupogen™".
Changes in PSQI global and component scores from baseline were analyzed for differences at endpoint among treatment groups using the ANCOVA model.
Other efficacy endpoints were analyzed using the ANCOVA model described for the primary endpoint, with the baseline value for the endpoint in question as an additional linear covariate.
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Perceived response rates, defined as a reduction of at least 50% from the baseline MADRS-S score at week 8, and perceived remission rates, defined using the cut-off value revealed in the ROC analysis, were also compared using a logistic model with the same explanatory factors and covariate as those used in the ANCOVA model described above.
Questions on numeric ordinal scales were analysed using the same ANCOVA model as the primary efficacy endpoint, or by ANCOVA with factors for treatment group and centre and covariates for the baseline throat soreness and the relevant baseline score for the specific question.
For indices of βCF, descriptive statistics and 95% CIs for the changes from baseline were provided; LS mean differences versus placebo at week 26 were assessed using the same ANCOVA model as for the primary endpoint.
Secondary efficacy variables were analysed using the same ANCOVA model as described for the primary analysis, with the exception of the incidence of exertion-related symptoms during the 6 min walk test and global assessment results, for which Fisher's Exact test was used.
The potential treatment-by-ethnicity interaction (performed on the mITT population) and other secondary variables were also tested using this ancova model.
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