|
Day 1
| | | | | | |
|---|
|
AST
|
Est (95% CI)
|
PC
|
P1
|
P2
|
P3A
|
P3B
|
|---|
|
PC
|
198.8 (8.5 to 389.1)
| |
**
|
NS
|
***
|
NS
|
|
P1
|
526.0 (335.7 to 716.3)
|
**
| |
***
|
***
|
*
|
|
P2
|
79.4 (−110.9 to 269.7)
|
NS
|
***
| |
***
|
NS
|
|
P3A
|
1123.2 (932.9 to 1313.5)
|
***
|
***
|
***
| |
***
|
|
P3B
|
246.4 (56.1 to 436.7)
|
NS
|
*
|
NS
|
***
| |
|
LDH
|
Est (95% CI)
|
PC
|
P1
|
P2
|
P3A
|
P3B
|
|
PC
|
78.5 (−119.6 to 276.6)
| |
NS
|
NS
|
***
|
NS
|
|
P1
|
299.2 (101.1 to 497.3)
|
NS
| |
NS
|
***
|
NS
|
|
P2
|
40.0 (−158.1 to 238.1)
|
NS
|
NS
| |
***
|
NS
|
|
P3A
|
795.4 (597.3 to 993.5)
|
***
|
***
|
***
| |
***
|
|
P3B
|
43.3 (−154.8 to 241.4)
|
NS
|
NS
|
NS
|
***
| |
|
CK
|
Est (95% CI)
|
PC
|
P1
|
P2
|
P3A
|
P3B
|
|
PC
|
7.2 (4.0 to 12.9)
| |
***
|
NS
|
***
|
NS
|
|
P1
|
37.8 (21.1 to 67.7)
|
***
| |
***
|
NS
|
**
|
|
P2
|
3.9 (2.2 to 7.0)
|
NS
|
***
| |
***
|
*
|
|
P3A
|
74.2 (41.5 to 132.8)
|
***
|
NS
|
***
| |
***
|
|
P3B
|
11.0 (6.2 to 19.7)
|
NS
|
**
|
*
|
***
| |
|
Body Weight
|
Est (95% CI)
|
PC
|
P1
|
P2
|
P3A
|
P3B
|
|
PC
|
−0.9 (−4.5 to 2.7)
| |
NS
|
NS
|
**
|
NS
|
|
P1
|
0.5 (−3.1 to 4.1)
|
NS
| |
NS
|
***
|
*
|
|
P2
|
1.8 (−1.8 to 5.4)
|
NS
|
NS
| |
***
|
**
|
|
P3A
|
−8.5 (−12.1 to −4.9)
|
**
|
***
|
***
| |
NS
|
|
P3B
|
−5.1 (−8.7 to −1.5)
|
NS
|
*
|
**
|
NS
| |
|
Day 2
| | | | | | |
|
AST
|
Est (95% CI)
|
PC
|
P1
|
P2
|
P3A
|
P3B
|
|
PC
|
286.0 (34.2 to 537.8)
| |
NS
|
NS
|
***
|
NS
|
|
P1
|
362.9 (111.1 to 614.7)
|
NS
| |
NS
|
***
|
NS
|
|
P2
|
96.8 (−155.0 to 348.6)
|
NS
|
NS
| |
***
|
NS
|
|
P3A
|
1019.7 (767.9 to 1271.5)
|
***
|
***
|
***
| |
***
|
|
P3B
|
239.8 (−11.9 to 491.6)
|
NS
|
NS
|
NS
|
***
| |
|
LDH
|
Est (95% CI)
|
PC
|
P1
|
P2
|
P3A
|
P3B
|
|
PC
|
217.8 (13.7 to 421.9)
| |
NS
|
NS
|
NS
|
NS
|
|
P1
|
137.8 (−66.3 to 341.9)
|
NS
| |
NS
|
*
|
NS
|
|
P2
|
33.9 (−170.2 to 238.0)
|
NS
|
NS
| |
**
|
NS
|
|
P3A
|
430.1 (226.0 to 634.2)
|
NS
|
*
|
**
| |
**
|
|
P3B
|
72.2 (−131.9 to 276.3)
|
NS
|
NS
|
NS
|
**
| |
|
CK
|
Est (95% CI)
|
PC
|
P1
|
P2
|
P3A
|
P3B
|
|
PC
|
6.8 (3.3 to 13.8)
| |
NS
|
NS
|
*
|
NS
|
|
P1
|
8.6 (4.2 to 17.6)
|
NS
| |
*
|
NS
|
NS
|
|
P2
|
2.8 (1.4 to 5.8)
|
NS
|
*
| |
***
|
NS
|
|
P3A
|
21.9 (10.7 to 44.8)
|
*
|
NS
|
***
| |
***
|
|
P3B
|
4.2 (2.0 to 8.5)
|
NS
|
NS
|
NS
|
***
| |
|
Body Weight
|
Est (95% CI)
|
PC
|
P1
|
P2
|
P3A
|
P3B
|
|
PC
|
0.2 (−3.9 to 4.3)
| |
NS
|
NS
|
NS
|
NS
|
|
P1
|
1.9 (−2.2 to 6.0)
|
NS
| |
NS
|
NS
|
*
|
|
P2
|
2.1 (−2.0 to 6.2)
|
NS
|
NS
| |
*
|
*
|
|
P3A
|
−2.4 (−6.5 to 1.7)
|
NS
|
NS
|
*
| |
NS
|
|
P3B
|
−3.5 (−7.6 to 0.6)
|
NS
|
*
|
*
|
NS
| |
- PC control values, P1 protocol 1, P2 protocol 2, P3A protocol 3A, and P3B protocol 3B. Changes in AST, LDH and body weight are presented as day X – day 0 values; changes in CK are presented as fold increases day X/day 0 values (95% CI). The columns labelled PC, P1, P2, P3A and P3B summarise between treatment differences (NS = not significant, * < 0.05, ** < 0.01, *** < 0.001).
