A CCEPTED MANUSCRIPT
Figure legends:
Figure 1.
Enrollment and randomization of subjects according to the CONSORT Flow Diagram.
Figure 2.
Primary and Secondary endpoint. Mean Lewis Score per visit (A) and the primary
endpoint mean Lewis Score AUC ± SEM (B) per treatment arm. Median number of ulcers per visit
(C) and the secondary endpoint ulcer number AUC ± SEM (D) per treatment arm. * indicates p <
0.05. Effects sizes were 30% lower AUC in Bif195 arm (B) and 33% lower AUC in Bif195 arm
(D).
Figure 3.
Tertile-stratification of ulceration. Median ulcer numbers, both per visit (A, C and E)
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and mean ulcer number AUC ± SEM (B, D and F) from Video Capsule Endoscopy stratified on
small-intestinal tertiles (thirds of small intestine). * indicates p < 0.05.
Figure 4.
Other secondary endpoints measured in the trial. AUC ± SEM of the Pain module (A)
and total score (B) from in the GSRS questionnaire. AUC ± SEM of blood I-FABP (C), AUC ±
SEM of red spots from VCE (D), AUC ± SEM of fecal (E) and blood (F) calprotectin. * indicates p
< 0.05.
Figure 5.
Mean serum concentrations of Prostaglandin E2 per visit (A) and AUC ± SEM (B).
Mean serum concentrations of Thromboxane B2 per visit (C) and AUC ± SEM (D).
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