Table 8.

Secondary Efficacy Variable: Toe–Brachial Pressure Index (TBPI)

TBPI (mmHg)	ITT (N = 17)	mITT (N = 15)	PP (N = 14)
Visit 1 (screening)
Right
n	8	8	8
Mean (SD)	0.38 (0.20)	0.38 (0.20)	0.38 (0.20)
Median	0.31	0.31	0.31
Min/Max	0.12/0.70	0.12/0.70	0.12/0.70
Left
n	5	5	5
Mean (SD)	0.26 (0.20)	0.26 (0.20)	0.26 (0.20)
Median	0.23	0.23	0.23
Min/Max	0.08/0.56	0.08/0.56	0.08/0.56
Visit 7 (week 24)
Right
n	8	8	8
Mean (SD)	0.37 (0.27)	0.37(0.27)	0.37(0.27)
Median	0.33	0.33	0.33
Min/Max	0.09/0.77	0.09/0.77	0.09/0.77
Left
n	6	6	6
Mean (SD)	0.23 (0.19)	0.23 (0.19)	0.23 (0.19)
Median	0.17	0.17	0.17
Min/Max	0.11/0.61	0.11/0.61	0.11/0.61
Change
Right
n	8	8	8
Mean (SD)	−0.02 (0.20)	−0.02 (0.20)	−0.02 (0.20)
Median	−0.01	−0.01	−0.01
Min/Max	−0.44/0.18	−0.44/0.18	−0.44/0.18
95% CI	(−0.18, 0.15)	(−0.18, 0.15)	(−0.18, 0.15)
p Value*	0.8353	0.8353	0.8353
p Value†	0.9453	0.9453	0.9453
Left
n	5	5	5
Mean (SD)	−0.004 (0.06)	−0.004 (0.06)	−0.004 (0.06)
Median	0.03	0.03	0.03
Min/Max	−0.09/0.05	−0.09/0.05	−0.09/0.05
95% CI	(−0.08, 0.07)	(−0.08, 0.07)	(−0.08, 0.07)
p Value*	0.8868	0.8868	0.8868
p Value†	1.0000	1.0000	1.0000

ITT, intention to treat; mITT, modified intention to treat; PP, per protocol. Change = Visit 7 (week 24) − Visit 1 (screening).

*Paired t-test and †Wilcoxon Signed-Rank test.