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

Treatment day, Unit: kg Tolvaptan (N = 46) Placebo (N = 45) Adjust group difference (95% CI) p value
N Mean (SD) Change (SD) N Mean (SD) Change (SD)
Day 1 (baseline) 46 64.3 (14.7) -- 45 68.0 (14.5) -- -3.77 (-9.84, 2.30)- 0.2206
Day 2 46 63.4 (14.7) -0.84 (1.17)* 45 67.7 (14.3) -0.31 (0.86)* -0.55 (-0.98, -0.12) 0.0136
Day 3 45 62.6 (14.2) -1.13 (1.52)* 43 67.9 (14.7) -0.57 (1.06)* -0.59 (-1.15, -0.02) 0.0416
Day 4 42 62.9 (14.2) -1.20 (1.92)* 43 67.9 (14.7) -0.54 (1.26)* -0.69 (-1.40, -0.02) 0.0571
Post-dosing Day 5 43 62.1 (14.7) -1.45 (2.16)* 40 67.8 (15.0) -0.66 (1.31)* -0.81 (-1.62, -0.01) 0.0476
EOS 46 62.9 (14.8) -1.36 (2.13)* 45 67.4 (14.4) -0.59 (1.27)* -0.78 (-1.52, -0.04) 0.0394

Definition: EOS, end of study, the data represented with the result after 4-day tolvaptan treatment analyzed with the last observation carried forward (LOCF) method. 95% CI, confidence interval; SD, standard deviation.

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).