A CCEPTED MANUSCRIPT
Kolmogorov-Smirnov test for normality. In cases where datasets did not meet a normal distribution,
a log transformation was performed and check for normality performed again. In cases where a
normal distribution was still not obtained, the dataset was tested for intervention effects using a
non-parametric Mann-Whitney test. Curves in Figure 2,3 and 5 are shown as mean values or
medians, depending on normality. Bars in Figure 2-5 are always shown as mean ± SEM.
All authors had access to the study data and reviewed and approved the final manuscript.
Results Between July 31st, 2017 to October 24 th 2017, 109 subjects were screened for eligibility, of whom
75 were enrolled and randomized. Among the 75 randomized subjects, 9 subjects discontinued
during the intervention (n=3 active and n=6 placebo) and therefore efficacy data was obtained in a
total of 66 subjects, the analysis population (n=35 active arm and n=31 placebo, Figure 1).
MANUSCRIPT
The arms were in general similar in their baseline parameters as shown in Table 1, including gender
distribution, age, BMI and blood pressure. Accountability of both ASA and trial product were in
general very high in both two arms (Table 1).
This clinical trial met its primary endpoint with a statistically significantly (p=0.0376) lower AUC
Lewis Score, as captured by VCE, during the 8 weeks intervention in the Bif195 arm versus the
placebo arm (3040 ± 1340 arbitrary units (au) in the Bif195 arm vs 4351 ± 3195 au in the placebo
arm, Figure 2A and B). In addition, the trial met its secondary endpoint with a significantly
(p=0.0258) lower AUC ulcer number as captured using VCE during the intervention in Bif195
subjects versus the placebo group (50.4 ± 53.1 au in the Bif195 arm vs 75.2 ± 85.3 au in the placebo
arm, Figure 2C and D).
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