Table 3 Vital sign results (safety set)

DA-5521 (N = 23***) Mean±SD Placebo (N = 24) Mean±SD p-value

Pulse (beats/min) Baseline 63.00±9.49 63.42±8.15 0.8723*

2 h after drinking 70.04±9.71 74.17±9.92 0.1221&
Change from baseline 7.04±10.84 10.75±9.13
p-value** 0.0050 <.0001

10 h after drinking 69.39±6.88 71.38±6.51 0.4718*
Change from baseline 6.39±7.51 7.96±7.30
p-value** 0.0005 <.0001

Systolic blood pressure (mmHg) Baseline 117.74±7.89 115.54±7.70 0.3392*

2 h after drinking 109.22±10.97 111.96±8.53 0.0405*
Change from baseline -8.52±8.17 -3.58±7.88
p-value** <.0001 0.0359

10 h after drinking 116.74±8.87 115.83±8.71 0.3997&
Change from baseline -1.00±8.39 0.29±7.75
p-value** 0.5733 0.8553

Diastolic blood pressure (mmHg) Baseline 71.35±5.74 69.21±8.61 0.3236*

2 h after drinking 60.57±8.40 64.63±9.46 0.0108*
Change from baseline -10.78±6.58 -4.58±9.12
p-value** <.0001 0.0218

10 h after drinking 66.83±7.12 65.79±8.35 0.6765*
Change from baseline -4.52±6.58 -3.42±10.98
p-value** 0.0033 0.1410

Body weight (kg) Baseline 75.73±7.67 75.78±8.02 0.9846*

10 h after drinking 75.44±7.63 75.50±7.85 0.8561&
Change from baseline -0.29±0.37 -0.28±0.59
p-value** 0.0010 0.0307
Comparison between groups: p-value for the two-sample t-test
Comparison between groups: p-value for Wilcoxon rank-sum test
Comparison between groups: p-value for Paired t-test
Excluding one participant who dropped out after visit two (visit two: placebo, visit three: DA-5521)