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a Physical Health Score from baseline to study end.
b Mental Health Score from baseline to study end.
Mean values; p-values: change from baseline to study end, one-sample t-test for dependent samples.
The primary efficacy endpoint was mean change from baseline to study end in YMRS total score for all studies, excluding one 12-week study where the primary endpoint was treatment response, defined as ≥50% improvement from baseline in YMRS total score (Vieta et al. 2005).
In all four domains of the 4-point scale DAS significant improvements from baseline to study end were found in the INCO group (mean changes for hygiene: −0.7 ± 1.1, dressing −0.8 ± 1.1; limb position −1.0 ± 0.9, pain −0.8 ± 0.9; all p < 0.01, Wilcoxon-Mann Whitney test).
Conventional therapy with responder rates between 15.5 % and 26.9%% from baseline to study end, only partially resulted in functional improvements and improved quality of life; changes in DAS domains "hygiene" and "limb position" (p < 0.01) and mental health dimension of SF-12 (p = 0.02) were significant from baseline in this group.
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Figure 1 summarizes overall headache parameters comparing baseline to study end-point.
There was no notable change in transaminase levels from baseline to study-end in both patients with mild renal impairment and normal renal function between vildagliptin and TZD.
Note: Overall effect size was from baseline to study end-point (10 weeks ATX treatment); Incremental effect size from double-blind randomization to study end-point (6 weeks augmentation treatment).
Effect sizes were also calculated on the secondary outcome measures to determine the overall treatment response (10-week treatment from baseline to study end-point) and the incremental effect size (6-week double-blind randomization to study end-point).
The AUC0 120 of the baseline measurements was increased by 27.7%% from baseline (19.3 mm × sec) to study end (24.6 mm × sec).
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