Table 1.

Change in patient-reported outcomes – titration period

Instrument	All patients		ITT patients
	Mean change	p-value	Mean change	p-value
Short Form-36v2 Health Surveya
Physical Functioning	6.7	<0.0001	8.0	<0.0001
Role-Physical	7.7	<0.0001	9.1	<0.0001
Bodily Pain	9.8	<0.0001	11.6	<0.0001
General Health	2.3	<0.0001	3.1	<0.0001
Vitality	4.6	<0.0001	5.8	<0.0001
Social Functioning	5.0	<0.0001	7.0	<0.0001
Role-Emotional	3.4	<0.0001	4.7	<0.0001
Mental Health	2.3	<0.0001	3.5	<0.0001
Physical Component Score	8.2	<0.0001	9.6	<0.0001
Mental Component Score	1.6	0.0026	2.9	<0.0001
EuroQol-5 Dimensions 3-Levelb
Summary Index	0.12	<0.0001	0.14	<0.0001
Visual Analog Scale	8.16	<0.0001	9.84	<0.0001
Work Productivity and Activity Impairment Questionnaire: Specific Health Problemc
Percentage work time missed due to low back pain	−1.3	0.3822	−4.9	0.0017
Percentage impairment while working due to low back pain	−22.4	<0.0001	−25.9	<0.0001
Percentage overall work impairment due to low back pain	−21.6	<0.0001	−26.9	<0.0001
Percentage activity impairment due to low back pain	−27.2	<0.0001	−32.0	<0.0001

ITT intent to treat

^aHigher scores indicate a better health-related quality of life. ^bHigher scores indicate a better health. ^cHigher scores indicate less productivity/greater impairment