|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
0 |
Screening |
1 |
38.00 |
5/21/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
1 |
Visit 1 |
58 |
39.00 |
7/17/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
2 |
Visit 2 |
107 |
38.00 |
9/4/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
3 |
Visit 3 |
162 |
34.00 |
10/29/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
4 |
Visit 4 |
218 |
35.00 |
12/24/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
5 |
Visit 5 |
284 |
32.00 |
2/28/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
6 |
Visit 6 |
336 |
35.00 |
4/20/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
7 |
End of Study |
355 |
37.00 |
5/9/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
0 |
Screening |
1 |
0.65 |
5/21/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
1 |
Visit 1 |
58 |
0.70 |
7/17/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
2 |
Visit 2 |
107 |
1.00 |
9/4/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
3 |
Visit 3 |
162 |
1.25 |
10/29/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
4 |
Visit 4 |
218 |
1.55 |
12/24/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
5 |
Visit 5 |
284 |
1.30 |
2/28/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
6 |
Visit 6 |
336 |
0.95 |
4/20/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
7 |
End of Study |
355 |
0.75 |
5/9/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.35 |
5/21/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
58 |
0.30 |
7/17/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
107 |
1.20 |
9/4/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
162 |
4.80 |
10/29/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
218 |
6.00 |
12/24/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
284 |
3.50 |
2/28/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
336 |
1.60 |
4/20/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
355 |
0.80 |
5/9/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.30 |
5/21/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
58 |
0.25 |
7/17/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
107 |
1.00 |
9/4/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
162 |
4.50 |
10/29/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
218 |
5.75 |
12/24/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
284 |
3.00 |
2/28/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
336 |
1.20 |
4/20/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
355 |
0.60 |
5/9/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
0 |
Screening |
1 |
9.00 |
5/21/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
1 |
Visit 1 |
58 |
9.00 |
7/17/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
2 |
Visit 2 |
107 |
12.00 |
9/4/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
3 |
Visit 3 |
162 |
19.00 |
10/29/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
4 |
Visit 4 |
218 |
30.00 |
12/24/15 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
5 |
Visit 5 |
284 |
25.00 |
2/28/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
6 |
Visit 6 |
336 |
18.00 |
4/20/16 |
|
01-001 |
1 |
30 |
F |
Other/Mixed |
Placebo |
5/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
7 |
End of Study |
355 |
12.00 |
5/9/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
0 |
Screening |
1 |
25.26 |
5/30/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
1 |
Visit 1 |
52 |
41.36 |
7/20/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
2 |
Visit 2 |
113 |
38.40 |
9/19/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
3 |
Visit 3 |
162 |
41.22 |
11/7/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
4 |
Visit 4 |
228 |
40.53 |
1/12/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
5 |
Visit 5 |
283 |
64.40 |
3/7/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
6 |
Visit 6 |
343 |
33.81 |
5/6/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
7 |
End of Study |
372 |
34.89 |
6/4/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
0 |
Screening |
1 |
1.40 |
5/30/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
1 |
Visit 1 |
52 |
0.00 |
7/20/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
2 |
Visit 2 |
113 |
0.54 |
9/19/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
3 |
Visit 3 |
162 |
0.91 |
11/7/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
4 |
Visit 4 |
228 |
0.94 |
1/12/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
5 |
Visit 5 |
283 |
0.70 |
3/7/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
6 |
Visit 6 |
343 |
0.64 |
5/6/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
7 |
End of Study |
372 |
0.83 |
6/4/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.00 |
5/30/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
52 |
0.58 |
7/20/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
113 |
0.44 |
9/19/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
162 |
0.81 |
11/7/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
228 |
0.35 |
1/12/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
283 |
0.92 |
3/7/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
343 |
0.57 |
5/6/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
372 |
0.91 |
6/4/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.00 |
5/30/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
52 |
0.86 |
7/20/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
113 |
0.30 |
9/19/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
162 |
0.12 |
11/7/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
228 |
0.14 |
1/12/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
283 |
0.00 |
3/7/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
343 |
0.11 |
5/6/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
372 |
0.50 |
6/4/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
0 |
Screening |
1 |
22.44 |
5/30/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
1 |
Visit 1 |
52 |
0.00 |
7/20/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
2 |
Visit 2 |
113 |
17.97 |
9/19/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
3 |
Visit 3 |
162 |
15.21 |
11/7/15 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
4 |
Visit 4 |
228 |
18.38 |
1/12/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
5 |
Visit 5 |
283 |
24.37 |
3/7/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
6 |
Visit 6 |
343 |
11.63 |
5/6/16 |
|
01-002 |
1 |
24 |
F |
Black |
Treatment A |
5/30/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
7 |
End of Study |
372 |
23.49 |
6/4/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
0 |
Screening |
1 |
36.77 |
8/13/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
1 |
Visit 1 |
55 |
50.39 |
10/6/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
2 |
Visit 2 |
106 |
35.19 |
11/26/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
3 |
Visit 3 |
173 |
58.32 |
2/1/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
4 |
Visit 4 |
220 |
39.07 |
3/19/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
5 |
Visit 5 |
285 |
41.87 |
5/23/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
6 |
Visit 6 |
337 |
48.43 |
7/14/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
7 |
End of Study |
365 |
48.09 |
8/11/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
0 |
Screening |
1 |
0.90 |
8/13/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
1 |
Visit 1 |
55 |
2.07 |
10/6/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
2 |
Visit 2 |
106 |
1.39 |
11/26/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
3 |
Visit 3 |
173 |
1.15 |
2/1/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
4 |
Visit 4 |
220 |
0.80 |
3/19/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
5 |
Visit 5 |
285 |
1.51 |
5/23/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
6 |
Visit 6 |
337 |
1.42 |
7/14/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
7 |
End of Study |
365 |
0.85 |
8/11/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.41 |
8/13/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
55 |
0.44 |
10/6/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
106 |
0.06 |
11/26/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
173 |
0.16 |
2/1/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
220 |
0.65 |
3/19/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
285 |
0.47 |
5/23/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
337 |
0.38 |
7/14/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
365 |
0.00 |
8/11/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.33 |
8/13/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
55 |
0.25 |
10/6/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
106 |
0.47 |
11/26/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
173 |
0.31 |
2/1/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
220 |
0.28 |
3/19/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
285 |
0.00 |
5/23/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
337 |
0.16 |
7/14/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
365 |
0.00 |
8/11/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
0 |
Screening |
1 |
5.52 |
8/13/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
1 |
Visit 1 |
55 |
7.60 |
10/6/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
2 |
Visit 2 |
106 |
6.30 |
11/26/15 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
3 |
Visit 3 |
173 |
12.11 |
2/1/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
4 |
Visit 4 |
220 |
11.80 |
3/19/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
5 |
Visit 5 |
285 |
14.28 |
5/23/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
6 |
Visit 6 |
337 |
20.83 |
7/14/16 |
|
01-003 |
1 |
43 |
F |
Hispanic |
Placebo |
8/13/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
7 |
End of Study |
365 |
6.42 |
8/11/16 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
0 |
Screening |
1 |
42.74 |
1/12/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
1 |
Visit 1 |
60 |
46.64 |
3/12/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
2 |
Visit 2 |
117 |
28.46 |
5/8/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
3 |
Visit 3 |
161 |
29.91 |
6/21/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
4 |
Visit 4 |
224 |
43.71 |
8/23/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
5 |
Visit 5 |
281 |
38.18 |
10/19/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
6 |
Visit 6 |
329 |
37.85 |
12/6/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
7 |
End of Study |
367 |
48.37 |
1/13/16 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
0 |
Screening |
1 |
0.64 |
1/12/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
1 |
Visit 1 |
60 |
0.74 |
3/12/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
2 |
Visit 2 |
117 |
0.53 |
5/8/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
3 |
Visit 3 |
161 |
0.53 |
6/21/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
4 |
Visit 4 |
224 |
0.87 |
8/23/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
5 |
Visit 5 |
281 |
1.06 |
10/19/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
6 |
Visit 6 |
329 |
1.91 |
12/6/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
7 |
End of Study |
367 |
0.63 |
1/13/16 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.60 |
1/12/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
60 |
0.63 |
3/12/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
117 |
0.31 |
5/8/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
161 |
0.54 |
6/21/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
224 |
0.18 |
8/23/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
281 |
0.40 |
10/19/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
329 |
0.42 |
12/6/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
367 |
0.00 |
1/13/16 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.43 |
1/12/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
60 |
0.30 |
3/12/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
117 |
0.77 |
5/8/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
161 |
0.00 |
6/21/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
224 |
0.47 |
8/23/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
281 |
0.00 |
10/19/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
329 |
0.11 |
12/6/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
367 |
0.43 |
1/13/16 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
0 |
Screening |
1 |
18.38 |
1/12/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
1 |
Visit 1 |
60 |
9.85 |
3/12/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
2 |
Visit 2 |
117 |
6.87 |
5/8/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
3 |
Visit 3 |
161 |
14.70 |
6/21/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
4 |
Visit 4 |
224 |
24.41 |
8/23/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
5 |
Visit 5 |
281 |
19.40 |
10/19/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
6 |
Visit 6 |
329 |
20.07 |
12/6/15 |
|
01-004 |
1 |
42 |
F |
Hispanic |
Placebo |
1/12/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
7 |
End of Study |
367 |
20.82 |
1/13/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
0 |
Screening |
1 |
49.81 |
11/11/15 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
1 |
Visit 1 |
61 |
31.14 |
1/10/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
2 |
Visit 2 |
119 |
51.96 |
3/8/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
3 |
Visit 3 |
171 |
50.31 |
4/29/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
4 |
Visit 4 |
225 |
54.23 |
6/22/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
5 |
Visit 5 |
277 |
38.10 |
8/13/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
6 |
Visit 6 |
338 |
39.39 |
10/13/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
7 |
End of Study |
363 |
43.36 |
11/7/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
0 |
Screening |
1 |
1.41 |
11/11/15 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
1 |
Visit 1 |
61 |
0.23 |
1/10/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
2 |
Visit 2 |
119 |
1.37 |
3/8/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
3 |
Visit 3 |
171 |
1.22 |
4/29/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
4 |
Visit 4 |
225 |
0.84 |
6/22/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
5 |
Visit 5 |
277 |
0.77 |
8/13/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
6 |
Visit 6 |
338 |
1.18 |
10/13/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
7 |
End of Study |
363 |
1.32 |
11/7/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
1.26 |
11/11/15 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
61 |
0.00 |
1/10/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
119 |
0.00 |
3/8/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
171 |
0.51 |
4/29/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
225 |
0.33 |
6/22/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
277 |
0.50 |
8/13/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
338 |
0.34 |
10/13/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
363 |
0.75 |
11/7/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.31 |
11/11/15 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
61 |
0.00 |
1/10/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
119 |
0.70 |
3/8/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
171 |
0.00 |
4/29/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
225 |
0.00 |
6/22/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
277 |
0.31 |
8/13/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
338 |
0.75 |
10/13/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
363 |
0.25 |
11/7/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
0 |
Screening |
1 |
3.15 |
11/11/15 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
1 |
Visit 1 |
61 |
2.29 |
1/10/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
2 |
Visit 2 |
119 |
12.61 |
3/8/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
3 |
Visit 3 |
171 |
13.81 |
4/29/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
4 |
Visit 4 |
225 |
17.50 |
6/22/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
5 |
Visit 5 |
277 |
7.89 |
8/13/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
6 |
Visit 6 |
338 |
20.49 |
10/13/16 |
|
01-005 |
1 |
51 |
M |
White |
Treatment B |
11/11/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
7 |
End of Study |
363 |
16.05 |
11/7/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
0 |
Screening |
1 |
51.10 |
11/21/15 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
1 |
Visit 1 |
58 |
35.03 |
1/17/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
2 |
Visit 2 |
107 |
52.96 |
3/6/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
3 |
Visit 3 |
174 |
61.20 |
5/12/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
4 |
Visit 4 |
222 |
31.53 |
6/29/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
5 |
Visit 5 |
274 |
45.90 |
8/20/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
6 |
Visit 6 |
329 |
27.28 |
10/14/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
7 |
End of Study |
356 |
47.90 |
11/10/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
0 |
Screening |
1 |
1.05 |
11/21/15 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
1 |
Visit 1 |
58 |
0.47 |
1/17/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
2 |
Visit 2 |
107 |
0.52 |
3/6/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
3 |
Visit 3 |
174 |
0.98 |
5/12/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
4 |
Visit 4 |
222 |
2.55 |
6/29/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
5 |
Visit 5 |
274 |
0.97 |
8/20/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
6 |
Visit 6 |
329 |
2.00 |
10/14/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
7 |
End of Study |
356 |
0.75 |
11/10/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.18 |
11/21/15 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
58 |
0.34 |
1/17/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
107 |
0.32 |
3/6/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
174 |
0.00 |
5/12/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
222 |
0.09 |
6/29/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
274 |
0.00 |
8/20/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
329 |
0.00 |
10/14/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
356 |
0.23 |
11/10/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.00 |
11/21/15 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
58 |
0.57 |
1/17/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
107 |
0.54 |
3/6/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
174 |
0.00 |
5/12/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
222 |
0.00 |
6/29/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
274 |
0.12 |
8/20/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
329 |
0.00 |
10/14/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
356 |
0.21 |
11/10/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
0 |
Screening |
1 |
14.02 |
11/21/15 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
1 |
Visit 1 |
58 |
14.10 |
1/17/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
2 |
Visit 2 |
107 |
14.18 |
3/6/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
3 |
Visit 3 |
174 |
18.60 |
5/12/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
4 |
Visit 4 |
222 |
7.73 |
6/29/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
5 |
Visit 5 |
274 |
1.54 |
8/20/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
6 |
Visit 6 |
329 |
4.53 |
10/14/16 |
|
01-008 |
1 |
53 |
F |
Black |
Treatment B |
11/21/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
7 |
End of Study |
356 |
22.92 |
11/10/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
0 |
Screening |
1 |
15.34 |
11/25/15 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
1 |
Visit 1 |
57 |
40.64 |
1/20/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
2 |
Visit 2 |
116 |
57.93 |
3/19/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
3 |
Visit 3 |
166 |
37.61 |
5/8/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
4 |
Visit 4 |
218 |
49.27 |
6/29/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
5 |
Visit 5 |
286 |
35.15 |
9/5/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
6 |
Visit 6 |
339 |
58.47 |
10/28/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
7 |
End of Study |
358 |
47.24 |
11/16/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
0 |
Screening |
1 |
0.92 |
11/25/15 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
1 |
Visit 1 |
57 |
0.68 |
1/20/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
2 |
Visit 2 |
116 |
0.46 |
3/19/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
3 |
Visit 3 |
166 |
1.18 |
5/8/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
4 |
Visit 4 |
218 |
1.07 |
6/29/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
5 |
Visit 5 |
286 |
0.44 |
9/5/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
6 |
Visit 6 |
339 |
2.02 |
10/28/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
7 |
End of Study |
358 |
1.63 |
11/16/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.34 |
11/25/15 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
57 |
0.00 |
1/20/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
116 |
1.11 |
3/19/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
166 |
0.00 |
5/8/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
218 |
0.43 |
6/29/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
286 |
0.21 |
9/5/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
339 |
0.46 |
10/28/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
358 |
0.33 |
11/16/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.35 |
11/25/15 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
57 |
0.67 |
1/20/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
116 |
0.58 |
3/19/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
166 |
0.41 |
5/8/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
218 |
0.00 |
6/29/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
286 |
0.38 |
9/5/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
339 |
0.00 |
10/28/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
358 |
0.00 |
11/16/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
0 |
Screening |
1 |
22.42 |
11/25/15 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
1 |
Visit 1 |
57 |
14.17 |
1/20/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
2 |
Visit 2 |
116 |
19.16 |
3/19/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
3 |
Visit 3 |
166 |
0.00 |
5/8/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
4 |
Visit 4 |
218 |
13.83 |
6/29/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
5 |
Visit 5 |
286 |
9.96 |
9/5/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
6 |
Visit 6 |
339 |
9.28 |
10/28/16 |
|
01-009 |
1 |
44 |
M |
White |
Treatment B |
11/25/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
7 |
End of Study |
358 |
14.94 |
11/16/16 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
0 |
Screening |
1 |
40.18 |
1/6/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
1 |
Visit 1 |
56 |
36.41 |
3/2/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
2 |
Visit 2 |
107 |
36.61 |
4/22/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
3 |
Visit 3 |
168 |
30.45 |
6/22/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
4 |
Visit 4 |
224 |
36.69 |
8/17/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
5 |
Visit 5 |
279 |
52.82 |
10/11/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
6 |
Visit 6 |
341 |
56.51 |
12/12/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Albumin |
35 |
55 |
g/L |
7 |
End of Study |
367 |
33.14 |
1/7/16 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
0 |
Screening |
1 |
0.17 |
1/6/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
1 |
Visit 1 |
56 |
1.13 |
3/2/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
2 |
Visit 2 |
107 |
2.30 |
4/22/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
3 |
Visit 3 |
168 |
0.79 |
6/22/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
4 |
Visit 4 |
224 |
1.60 |
8/17/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
5 |
Visit 5 |
279 |
0.64 |
10/11/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
6 |
Visit 6 |
341 |
0.85 |
12/12/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Alkaline phosphatase (ALP) |
0.5 |
1.5 |
ukat/L |
7 |
End of Study |
367 |
0.67 |
1/7/16 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.33 |
1/6/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
56 |
0.00 |
3/2/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
107 |
0.57 |
4/22/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
168 |
0.61 |
6/22/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
224 |
0.39 |
8/17/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
279 |
0.72 |
10/11/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
341 |
0.23 |
12/12/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, alanine (ALT) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
367 |
0.34 |
1/7/16 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
0 |
Screening |
1 |
0.49 |
1/6/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
1 |
Visit 1 |
56 |
0.42 |
3/2/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
2 |
Visit 2 |
107 |
0.24 |
4/22/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
3 |
Visit 3 |
168 |
0.19 |
6/22/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
4 |
Visit 4 |
224 |
0.00 |
8/17/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
5 |
Visit 5 |
279 |
0.11 |
10/11/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
6 |
Visit 6 |
341 |
0.30 |
12/12/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Aminotransferase, aspartate (AST) |
0 |
0.58 |
pkat/L |
7 |
End of Study |
367 |
0.55 |
1/7/16 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
0 |
Screening |
1 |
10.79 |
1/6/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
1 |
Visit 1 |
56 |
20.88 |
3/2/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
2 |
Visit 2 |
107 |
10.57 |
4/22/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
3 |
Visit 3 |
168 |
22.56 |
6/22/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
4 |
Visit 4 |
224 |
14.02 |
8/17/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
5 |
Visit 5 |
279 |
6.07 |
10/11/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
6 |
Visit 6 |
341 |
13.05 |
12/12/15 |
|
01-010 |
1 |
35 |
F |
Black |
Treatment B |
1/6/15 |
Y |
Serum |
Total Bilirubin |
5.1 |
20.5 |
umol/L |
7 |
End of Study |
367 |
8.83 |
1/7/16 |