Table 1 Patient characteristics: phase I and II

Age, y, mean ± SD

13.8 ± 2.6

14 ± 2.7

13.4 ± 2.6

 Range

8–17

8–17

9–17

Gender, n (%)

 Female

18 (56)

12 (55)

6 (60)

 Male

14 (44)

10 (45)

4 (40)

Race/ethnicity, n (%)

 Caucasian

26 (81)

17 (77)

9 (90)

 African American

3 (9)

3 (14)

–

 Asian

1 (3)

1 (5)

–

 Latino/a

2 (6)

1 (5)

1 (10)

PUCAI total score, n (%)

 0

19 (59)

19 (86)

–

 5

3 (9)

3 (14)

–

 10

1 (3)

–

1 (10)

 15

1 (3)

–

1 (10)

 20

4 (13)

–

4 (40)

 35

1 (3)

–

1 (10)

 45

2 (6)

–

2 (20)

 55

1 (3)

–

1 (10)

Age, y, mean ± SD

12.84 ± 2.38

11.91 ± 2.11

14.06 ± 2.39

 Median

13

12

14

 Range

8–17

8–16

10–17

Gender, n (%)

 Female

22 (58)

12 (55)

12 (67)

 Male

16 (42)

10 (45)

6 (33)

PUCAI total score, n (%)

n = 40^a

n = 22^b

n = 18^b

 Average score, mean ± SD

12.25 ± 14.36

1.81 ± 2.46

25.00 ± 12.37

 Range

0–45

0–5

10–45

  0

14 (35)

14 (64)

–

  5

8 (20)

8 (36)

–

  10

4 (10)

–

4 (22)

  15

2 (5)

–

2 (11)

  20

2 (5)

–

2 (11)

  25

4 (10)

–

4 (22)

  35

2 (5)

–

2 (11)

  40

2 (5)

–

2 (11)

  45

2 (5)

–

2 (11)