Table 1 Baseline characteristics of patients. mITT modified intention to treat population, PP per protocol population, n sample size. Displayed are absolute and relative numbers and p-Value of two-sided chi-squared-test for gender and Tx random stratum. For continuous parameters mean, standard deviation, median, minimum and maximum values are depicted and compared by two-sided student’s t-test.

n

38

46

25

35

Gender, male (%)

23 (60.5%)

24 (52.2%)

0.443

15 (60.0%)

18 (51.4%)

0.511

Age, years

17.7 ± 1.7 (17 / 16–23)

17.4 ± 1.4 (17 / 15–22)

0.348

17.7 ± 1.7 (17 / 16–23)

17.4 ± 1.2 (17 / 16–22)

0.467

Height, cm

166.0 ± 12.0 (168 0.5/ 130–185)

166.2 ± 10.2 (167 / 130–186)

0.932

165.2 ± 12.2 (169/ 130–185)

166.8 ± 8.2 (167 / 151–183)

0.550

Time since Tx, years

8.1 ± 4.7 (7.5/ 0–15)

5.7 ± 4.6

(4.5/ 0–17)

0.024

6.8 ± 4.3 (7/ 0–15)

5.2 ± 4.3 (4/ 0–17)

0.164

Randomization stratum

1 (male, time since Tx < 5 y)

7 (18.4%)

13 (28.3%)

0.205

6 (24.0%)

10 (28.6%)

0.618

2 (male, time since Tx ≥ 5 y)

16 (42.1%)

11 (23.9%)

9 (36.0%)

8 (22.9%)

3 (female, time since Tx < 5 y)

6 (15.8%)

13 (28.3%)

5 (20.0%)

11 (31.4%)

4 (female, time since Tx ≥ 5 y)

9 (23.7%)

9 (19.6%)

5 (20.0%)

6 (17.1%)