|
COMP (ng/mL)
|
Analytical method
|
Type of analysis
|
Time point (Days)
|
Placebo (n = 27)
|
GC (n = 28)
|
UC-II (n = 27)
|
p value (95 % CI)
|
|---|
|
Overalla
|
GC vs PBO
|
UC-II vs PBO
|
UC-II vs GC
|
|---|
|
≥285
|
ANCOVA
|
mITT
|
180
|
−368 ± 41.7
|
−396 ± 40.9
|
−574 ± 41.6
|
0.002
|
0.88 (−168 to 112)
|
0.002b (−347 to −65)
|
0.009c (−317 to −38)
|
|
MMRM
|
mITT
|
180
|
−351 ± 44.1
|
−398 ± 41.1
|
−540 ± 44.2
|
0.006
|
0.71 (−188 to 94)
|
0.006b (−330 to −48)
|
0.048c (−282 to −1)
|
|
iAUCd
|
ITT
|
1 to 180
|
−1351 ± 212
|
−1582 ± 204
|
−2384 ± 207
|
0.003
|
0.72 (−934 to 473)
|
0.002b (−1741 to −325)
|
0.02c (−1498 to −107)
|
| | | | |
(n = 26)
|
(n = 29)
|
(n = 26)
| | | | |
|
<285
|
ANCOVA
|
mITT
|
180
|
−463 ± 38.8
|
−508 ± 36.6
|
−526 ± 38.7
|
0.48
|
0.67 (−173 to 82)
|
0.49 (−195 to 68)
|
0.94 (−145 to 109)
|
|
MMRM
|
mITT
|
180
|
−442 ± 38.2
|
−493 ± 37.3
|
−521 ± 38.1
|
0.34
|
0.60 (−178 to 76)
|
0.32 (−208 to 50)
|
0.86 (−155 to 100)
|
|
iAUCe
|
ITT
|
1 to 180
|
−1626 ± 185
|
−1908 ± 178
|
−1902 ± 185
|
0.49
|
0.52 (−896 to 333)
|
0.55 (−902 to 350)
|
0.99 (−607 to 618)
|
- Values presented as Mean ± SE
-
aOverall p value was obtained by comparing the mean changes among the three groups using ANCOVA
-
bSignificant difference between the UC-II and the placebo groups using Tukey-Kramer test
-
cSignificant difference between the UC-II and the GC groups using Tukey-Kramer test
-
dNumber of subjects used for analyses, 27, placebo; 29, GC; 28, UC-II
-
eNumber of subjects used for analyses, 27, placebo; 29, GC; 27, UC-II
