Table 4.

Secondary patient-reported outcome means (SEM)

	Time-point
	Baseline	w1	w3	w5	w7	Post
Standard group
ITT mean	15.41 (0.63)	15.04 (0.64)	12.31 (0.70)	11.66 (0.71)	10.41 (0.71)	8.81 (0.70)
ITT median	15	14	11	12	10.5	10
PP mean	15.08 (0.68)	14.47 (0.81)	12.00 (0.77)	11.00 (0.78)	10.00 (0.96)	8.37 (0.99)
PP median	15	14	11	10	8.5	8
Enhanced group
ITT mean	16.57 (0.71)	15.09 (0.71)15.09 (0.71)	12.24 (0.72)	10.61* (0.72)	10.09 (0.74)	9.16 (0.74)
ITT median	15	13	11	9	9	7
PP mean	15.50 (0.62)	13.98 (0.63)	11.22 (0.79)	9.23 (0.67)	8.80 (0.68)(0.68)	7.85 (0.76)
PP median	15	13	11	8	9	6

PP per protocol, ITT intent to treat, SEM standard error of the mean, w week