Groups
 
Visit 1

Visit 2

Visit 3

Visit 4

Visit 5


Overall n = 56

Complete data n

32

38

44

44

25

(% of 'per protocol’ population)

(57)

(68)

(79)

(79)

(45)

SCI T4 and above n = 28

Complete data n

17

20

22

22

16

(% of 'per protocol’ population)

(61)

(71)

(79)

(79)

(57)

SCI T5 and below n = 11

Complete data n

6

6

8

10

5

(% of 'per protocol’ population)

(55)

(55)

(73)

(91)

(45)

Control group n = 17

Complete data n

9

12

14

12

4

(% of 'per protocol’ population)

(53)

(71)

(82)

(71)

(24)


Legend: The completeness of the main laboratory data was calculated for the three groups relative to the number of enrolled patients feasible for 'per protocol’ analysis. The sample size calculation takes a 50% rate of drop out or missing values into account. Considering the drop out rate < 10% at the current stage of the trial, a 60% rate of data completeness is acceptable. Critical rates of overall completeness are observed at visit 1 and visit 5 and relate mainly to the control group and to patients with neurological level T5 or below.