Table 1 Demographic and baseline characteristics (safety population)

Male, n (%)

14 (38.9)

14 (38.9)

16 (42.1)

44 (40.0)

Mean age, years (range)

37.9 (18–64)

41.5 (18–64)

40.3 (18–62)

39.9 (18–64)

Race, n (%)

 White

 African American/African heritage

 Asian

 Multiple

25 (69.4)

7 (19.4)

2 (5.6)

2 (5.6)

25 (69.5)

5 (13.9)

5 (13.9)

1 (2.8)

19 (50.0)

8 (21.1)

11 (28.9)

0

69 (62.7)

20 (18.2)

18 (16.3)

3 (2.7)

Baseline mean BI score (SD)

0.217 (0.0828)

0.224 (0.1166)

0.207 (0.1390)

0.216 (0.1148)

Baseline mean MGI score (SD)

2.115 (0.0721)

2.131

(0.0738)

2.099

(0.0879)

2.115 (0.0788)

Baseline mean TPI score (SD)

2.552

(0.2678)

2.501 (0.2861)

2.459 (0.2753)

2.503 (0.2766)

Stratification, n (%)

 Stratum 1: male, baseline NBS < 45

 Stratum 2: male, baseline NBS ≥ 45

 Stratum 3: female, baseline NBS < 45

 Stratum 4: female, baseline NBS ≥ 45

13 (36.1)

1 (2.8)

17 (47.2)

5 (13.9)

12 (33.3)

2 (5.6)

18 (50.0)

4 (11.1)

14 (36.8)

2 (5.3)

18 (47.4)

4 (10.5)

39 (35.5)

5 (4.5)

53 (48.2)

13 (11.8)