In many clinical trials, the primary focus is whether treatment groups differ with respect to the change from baseline to end of therapy in a continuous response variable.
Instead, we propose using all available data in a repeated measures model that is based on the nonlinear treatment response pattern to estimate the average change from baseline to end of therapy in each treatment group.
Although the dropout rate was high, treatment completers (i.e., patients who attended at least 10 sessions; n = 15) demonstrated significant reductions in all PTSD symptom clusters and cocaine use from baseline to end of treatment.
Average decreases, from baseline to end of intervention, in weight, BMI, and body fat percentage were 3.58 kg, 1.32 kg/m(2), and 2.14%, respectively.
From baseline to end of RT, those with baseline dysfunction had less of a decline in Role Functioning (P=.01) and Global Health Score (P=.04) domains.
The primary outcome is the mean change over time from baseline to end of study on the Montgomery Asberg Depression Rating Scale (MADRS).
A statistical significant difference in mean change on MADRS-score, between study groups, from baseline to end of study, is the primary outcome measure of the study.
Progressive disease at baseline, change in disease status from baseline to end of study, and increase in self-reported pain or nausea all had significant (P < 0.05) negative effects on QOL scores.
The primary efficacy measure was the change in Arizona Sexual Experiences Survey (ASEX) from baseline to end of treatment in an intent-to-treat analysis with last observation carried forward approach.
We also observed a trend toward increased mean relative mRNA levels of the NRF2 target HBG1 (p = 0.10) from baseline to end of treatment, but without significant changes in HbF protein.
