Thesis

52 CHAPTER 2 Table 2 Outcomes (intention-to-treat population) Change BoNT-A, mean ± SD 2-DL, %, mean ± SD B (95% CI) p DQ, % Baseline 28.7 ± 23.9 26.0 ± 21.8 - 8 Weeks 18.0 ± 19.6 7.1 ± 10.0 9.3 (1.4 to 17.2) 0.022 32 Weeks 24.8 ± 25.0 15.0 ± 17.4 VAS Baseline 82.1 ± 16.2 77.0 ± 15.7 - 8 Weeks 53.2 ± 32.3 28.6 ± 24.2 24.5 (13.2 to 35.7) < 0.001 32 Weeks 75.0 ± 23.0 45.6 ± 28.3 Change Change BoNT-A, n (%) I p 2-DL, n (%) I p DS *1 *2 *3 *4 *5 *1 *2 *3 *4 *5 Baseline - - 4 (15) 3 (12) 19 (73) - - - 2 (7) 8 (30) 17 (63) - 8 Weeks - 1 (4) 3 (12) 8 (31) 14 (54) -1.3 0.207 1 (4) 3 (11) 11 (41) 5 (18) 7 (26) -3.7 < 0.001 32 Weeks - 1 (4) 1 (4) 6 (23) 18 (69) 0 1.0 - 3 (11) 3 (11) 7 (26) 14 (52) -1.9 0.061 Change Change BoNT-A, n (%) I p 2-DL, n (%) I p DF ^1 ^2 ^3 ^4 ^1 ^2 ^3 ^4 Baseline - 1 (4) 9 (35) 16 (62) - - 2 (7) 11 (41) 14 (52) - 8 Weeks - 10 (38) 9 (35) 7 (27) -3.2 0.001 2 (7) 18 (67) 6 (22) 1 (4) -4.2 < 0.001 32 Weeks - 5 (19) 11 (42) 10 (38) -2.4 0.019 - 15 (56) 7 (26) 5 (19) -3.3 0.001 Abbreviations: BoNT-A = Botulinum neurotoxin type A; 2-DL = 2-duct ligation; DQ = Drooling Quotient; SD = Standard Deviation; CI = Confidence Interval; VAS = caregivers Visual Analogue Scale for severity of drooling over the past 2 weeks; DS = Drooling Severity; DF = Drooling Frequency; SD = Standard Deviation; p = p Value; *1 = Dry; *2 = Mild; *3 = Moderate; *4 = Severe; *5 = Profuse; ^1 = Never; ^2 = Occasional; ^3 = Frequent; ^4 = Constant

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