TABLE 4.

Showing the results for the primary outcome measure on the total PedsQL 3.0 CP scores using intent-to-treat (N = 382), per protocol (N = 339) and per treatment analysis (N = 283).

Variable	Intention to treat			Per IQI protocol			Per VSS treatment
	Intervention arm	Control arm	P value (t test)	Intervention arm	Control arm	P value (t test)	Intervention arm	Control arm	P value (t test)
Total PedsQL 3.0 baseline
N	189	193		146	193		90	193
Mean (SD)	53.5(SD 26.5)	49.8(SD 27.6)		53.9(SD26.3)	49.8(SD27.6)		52.4(SD 26.7)	49.8(SD27.6)
Median (IQR)	55.5(34.7, 76.1)	45.2(27.4, 74.2)		53(34.7, 76.6)	45.2(27.4, 74.2)		47.6(33.9, 74.2)	45.2(27.4, 74.2)
Total PedsQL 3.0 at follow up
N	164	162		130	162		86	162
Mean (SD)	60.4(SD27.2)	54.4(SD 27.5)		62.3(SD 26.9)	54.4(SD27.5)		61.6(SD 27.8)	54.4(SD27.5)
Median (IQR)	61.7(42.2, 83)	53, 2(32.2, 77.4)		63.3(43.5, 87.1)	53.2(32.2, 77.4)		64.9(41.9, 87.1)	53.2(32.2, 77.4)
Total PedsQL 3.0 difference			0.287			0.163			0.908
N	163	161		130	161		86	161
Mean (SD)	6.3(SD 22.2)	4.9(SD 23.2)		7.5(SD 22.4)	4.9(SD 23.2)		9(SD 9)	4.9(SD 23.2)
Median (IQR)	0(−2.4, 19.5)	0(0, 13.7)		0(−1.6, 20.1)	0(0, 13.7)		0(−2.4, 27.4)	0(0, 13.7)