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Baseline analyses will be performed to determine if the three study groups are comparable or not with respect to various variables including age, parity, and body weight.
For cost analysis, exploratory baseline analyses will be completed including calculation of mean index hospitalization cost, median index hospitalization cost, mean readmission cost, median readmission cost and measures of central tendency for both variables.
The results of the baseline analyses will be used to refine a set of more precise longitudinal hypotheses to be tested using the longitudinal data collected by repeat administration of the survey to the original cohort of respondents.
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Where variables exhibit marked imbalance at baseline, primary analyses will be repeated and adjustments will be made to check that this does not influence findings.
If significant differences in baseline characteristics are found, analyses will be repeated adjusting for these differences using ANOVA and logistic regression for multivariate analyses.
Separate baseline, efficacy, and safety analyses will be done for the induction and maintenance phases of the study.
Using baseline data from all participants, correlation analyses will be used to explore the interrelationship between diurnal cortisol patterns and subjective stress, psychiatric symptoms, motor deficits, memory test and general functioning.
Analyses will be adjusted for baseline values.
If necessary, analyses will be adjusted for baseline differences.
All analyses will be adjusted for baseline EQ-5D 5L score.
All analyses will be corrected for baseline values, gender and age.
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