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Supplement Table 3. Mean change in body weight from baseline to each post-baseline observation (PP population).

Treatment day, Unit: kg Tolvaptan (N = 42) Placebo (N = 39) Adjust group difference (95% CI) p value
N Mean (SD) Change (SD) N Mean (SD) Change (SD)
Day 1 (baseline) 42 64.3 (14.5) -- 39 68.0 (15.0) -- -4.00 (-10.51, 2.52) 0.2254
Day 2 42 63.1 (14.5) -0.87 (1.20)* 39 67.6 (14.8) -0.36 (0.88)* -0.53 (-1.00, -0.06) 0.0292
Day 3 42 62.8 (14.3) -1.18 (1.54)* 39 67.4 (15.0) -0.58 (1.07)* -0.63 (-1.23, -0.04) 0.0379
Day 4 41 63.3 (14.1) -1.20 (1.94)* 39 67.4 (15.0) -0.60 (1.29)* -0.64 (-1.38, -0.11) 0.0918
Post-dosing Day 5 42 62.5 (14.6) -1.45 (2.19)* 39 67.3 (14.9) -0.69 (1.31)* -0.78 (-1.60, 0.04) 0.0614
EOS 42 62.5 (14.6) -1.45 (2.19)* 39 67.3 (14.9) -0.69 (1.31)* -0.78 (-1.60, 0.04) 0.0614

Definition: Post-Dosing Day 5: treatment measurement at post Day 4 dosing examination visit. EOS, end of study, the data represented with the result of post-dosing day 5 analyzed with the last observation carried forward (LOCF) method.

p value: pair t-test for intragroup comparison; Post-Baseline ANCOVA Model: outcome = treatment + baseline level.

* With significant mean change compared to baseline value (intra p value < 0.05).