Use Instructions

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Table 18: Efficacy Summary: ITT Population
FIX-HF-5C2
FIX-HF-5C
Variable
OPTIMIZER
OPTIMIZER
Difference
1
Control
Difference
1
Peak VO2 (ml/kg/min)
Baseline
Mean ± SD (n)
15.0 ± 2.9 (60)
15.5 ± 2.6 (73)
-0.48 ± 2.76
15.4 ± 2.8 (86)
-0.36 ± 2.87
(min, max)
(9.8, 19.9)
(9.8, 19.7)
(9.1, 19.9)
[95% CI]
[14.2,15.8]
[14.9,16.1]
[-1.44, 0.47]
[14.8,16.0]
[-1.31, 0.60]
P-value
2
0.317
0.462
12 Weeks
Mean ± SD (n)
16.0 ± 3.3 (52)
15.6 ± 3.2 (67)
0.43 ± 3.25
15.2 ± 3.1 (70)
0.80 ± 3.20
(min, max)
(10.2, 22.2)
(9.0, 23.3)
(8.5, 21.9)
[95% CI]
[15.1,16.9]
[14.8,16.4]
[-0.76, 1.62]
[14.5,15.9]
[-0.36, 1.96]
P-value
2
0.478
0.174
Change Baseline to 12 Weeks
Mean ± SD (n)
0.77 ± 1.64 (52)
0.10 ± 2.34 (67)
0.67 ± 2.06
-0.35 ± 2.11 (70)
1.13 ± 1.92
(min, max)
(-5.30, 4.60)
(-7.35, 5.95)
(-6.10, 4.80)
[95% CI]
[0.32,1.23]
[-0.47,0.67]
[-0.09, 1.42]
[-0.86,0.15]
[0.43, 1.82]
P-value
2
0.001
0.716
0.082
0.164
0.002
24 Weeks
Mean ± SD (n)
16.2 ± 3.1 (52)
15.5 ± 3.5 (66)
0.73 ± 3.33
15.2 ± 3.3 (70)
1.06 ± 3.20
(min, max)
(10.2, 23.9)
(8.9, 23.2)
(8.8, 22.7)
[95% CI]
[15.4,17.1]
[14.6,16.3]
[-0.49, 1.95]
[14.4,15.9]
[-0.10, 2.21]
P-value
2
0.239
0.074
Change Baseline to 24 Weeks
Mean ± SD (n)
1.13 ± 1.50 (52)
-0.027 ± 2.745 (66)
1.15 ± 2.28
-0.50 ± 2.36 (70)
1.63 ± 2.04
(min, max)
(-2.60, 4.20)
(-7.30, 5.90)
(-6.85, 4.90)
[95% CI]
[0.71,1.54]
[-0.701,0.648]
[0.32, 1.99]
[-1.07,0.06]
[0.89, 2.37]
P-value
2
<.001
0.938
0.007
0.078
<.001
1
Compared to FIX-HF-5C2 OPTIMIZER Group.
2
Values are compared to baseline using the paired t-test, and differences are compared using the two-sample t-test without taking into account other time
points.