Mintek LV, LV-T Score†, 18.18%, P-value, ± 7.07%, Distance, Baseline, Distance, Baseline, ∆ in QOL, Composite, Six-Months, ∆ Distance, Six-Months, QOL Score at, QOL Score at

Stratos LV/LV-T Technical Manual 57

Table 15: Composite of Six Minute Walk Test and QOL

(Effectiveness)

	Study Group		Control Group		P-value*
Category	(N = 74)		(N = 38)
	Mean ± SE		Mean ± SE
Distance
Walked at	310.51	± 10.89	288.76	± 15.37	0.249
Baseline
Distance
Walked at	340.77	± 12.32	301.84	± 17.02	0.067
Six-Months
∆ Distance	30.26 ± 10.40		13.08 ± 13.05		0.322
Walked	17.27%	± 5.59%	8.71% ± 5.26%		0.326
QOL Score at	44.39	± 2.78	45.53	± 4.13	0.817
Baseline
QOL Score at	28.68	± 2.66	33.95	± 4.35	0.279
Six-Months
∆ in QOL	15.72± 2.83		11.58	± 3.45	0.376
			-13.42% ±
Score†	19.08% ± 12.21%				0.281
			34.54%
Composite	18.18%	± 7.07%	-2.36% ± 17.73%		0.030
Rate‡

*The calculated p-values are associated with a Student's t-test (2-sided) of the equality of means in the two groups, except for the p-value of the composite rate,

which is associated with a test of equivalence (non-inferiority).

† ∆ in QOL Score is calculated as the average of the individual differences between Baseline and Six-Months for each patient. Negative values for mean ∆ QOL in percent are possible when positive mean values for absolute changes in QOL are recorded. In some cases, small, negative changes in absolute QOL

scores resulted in relatively large percentage changes.

‡ The Composite Rate (=(∆ Distance Walked (%) + ∆ QOL Score (%)) / 2) is calculated for each patient and then averaged to obtain the Composite Rates. For all calculations, a positive number represents improvement from Baseline to Six-Months.