K 8 Week 4 Week eight Week 4 Week 8 Week four WeekParameterNRL001 five mgWeekWexner scores Screening 12.9 (3.11) (n = 108) Adjust -3.0 (4.04) (n = 108) 95 CI [-1.75.63] Vaizey scores -3.six (4.73) (n = 104) [-1.53.21] 13.three (3.21) (n = 108) -2.6 (three.53) (n = 108) [-1.41.97] -3.1 (3.80) (n = 94) [-1.00.81] -3.three (4.41) (n = 105) [-1.15.58] 13.three (3.07) (n = 117) -2.six (3.73) (n = 117) [-1.37.96]12.9 (3.00) (n = 107) -2.four (3.97) (n = 107)-3.five (4.46) (n = 106)0.6867 0.-4.5 (five.53) (n = 104) [-2.06.21]15.5 (3.57) (n = 108) -3.0 (4.43) (n = 108) [-1.32.53] -4.1 (four.77) (n = 93) [-1.72.65]15.three (3.62) (n = 116) -3.0 (four.56) (n = 115) [-1.31.50]-3.eight (five.14) (n = 103) [-1.39.89]15.3 (three.52) (n = 107) -3.1 (4.61) (n = 105)-4.0 (five.26) (n = 105)0.PDGF-AA Protein custom synthesis 9429 0.Screening 15.4 (three.70) (n = 108) Transform -3.three (four.82) (n = 108) 95 CI [-1.62.23] No. of FI episodes Screening 16.37 (17.16) (n = 105) Change -3.4 (14.41) (n = 102) 95 CI [-0.24.30] -6.two (11.64) (n = 93) [-1.68.52] 17.03 (17.79) (n = 106) -3.3 (8.58) (n = 91) [-0.79.99] -5.0 (ten.70) (n = 86) [-1.71.71] 17.38 (20.17) (n = 116) -5.2 (9.86) (n = 108) [-2.50.93]-7.0 (ten.48) (n = 96) [-3.88.31]19.31 (21.97) (n = 104) -6.three (14.65) (n = 102)-7.4 (15.55) (n = 94)0.2619 0.ap values calculated making use of ANCOVA with screening as covariate. No important treatment effect was observed between groupsInt J Colorectal Dis (2016) 31:1205SD typical deviation, CI confidence interval, mITT modified intent to treat, n number of sufferers, FI faecal incontinenceInt J Colorectal Dis (2016) 31:120520 18 16 14 Total Wexner Score 12 10 8 six 4 two 0 Screening Week 4 p=0.6867 Therapy: NRL001 five mg NRL001 7.five mg NRL001 10 mg Placebo Week eight p=0.Fig. three Patients’ Wexner scores at screening, week four and week eight (mITT population). Symbols would be the indicates, boxes are the interquartile variety, lines inside the boxes will be the median and whiskers will be the range. Nosignificant therapy effect with the transform from screening was observed at week four or week 8 (p values calculated utilizing ANCOVA with screening as covariate)a3.five 3 2.five p=0.18 two 1.5 1 Screening WeekLifestyleb3.5Coping/Behaviorp=0.NRL001 5 mg NRL001 7.five mg NRL001 10 mg Placebo2.five two 1.five 1 p=0.09 p=0.NRL001 five mg NRL001 7.five mg NRL001 10 mg PlaceboWeekScreeningWeekWeekc3.five 3 two.five 2 1.5 1 ScreeningDepression/self-perceptiond3.5Embarrassmentp=0.007 p=0.NRL001 five mg NRL001 7.5 mg NRL001 10 mg Placebo2.five 2 1.5 1 p=0.68 p=0.NRL001 five mg NRL001 7.5 mg NRL001 10 mg PlaceboWeekWeekScreeningWeekWeekFig. four Patients’ imply FIQoL scores at screening, week four and week eight (mITT population) for the 4 parameters: life style (a), coping/ behaviour (b), depression/self-perception (c) and embarrassment (d).MIF Protein Formulation p values for therapy effects calculated working with ANCOVA withscreening as covariate.PMID:23439434 Pairwise differences between placebo and NRL001 five mg were statistically important at both week 4 and week 8 at the 95 CI, calculated employing Dunnett’s technique within ANCOVA1212 Table 3 Wilcoxon p values calculated for the alter within the EQ-5D-5L Healthcare Questionnaire from screening at week four and week 8 (mITT population)Int J Colorectal Dis (2016) 31:1205QuestionComparison of NRL001 vs. placeboWilcoxon p worth Week 4 Week 8 0.34432 0.68848 0.78593 0.32080 0.49652 0.61766 0.03675 0.02401 0.13918 0.28540 0.57655 0.38680 0.07648 0.68457 0.Mobility5 mg 7.five mg 10 mg0.00353 0.16309 0.05261 0.12285 0.07852 0.44415 0.0007561 0.06087 0.02297 0.15276 0.33317 0.14695 0.18180 0.73124 0.Self-care5 mg 7.five mg ten mgActivity5 mg 7.5 mg 10 mgPain5 mg 7.five mg 10 mg five mg 7.5.
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