Table 2.

Differences from baseline in efficacy variables at different points in time for the intention-to-treat (ITT) and the per-protocol (PP) populations

Variable	ITT				PP
Relaxation	Exercise	Topiramate	p-value	Relaxation	Exercise	Topiramate	p-value
Attack frequency (n/month)
Treatment period	−0.97 ± 0.23	−0.65 ± 0.23	−0.70 ± 0.23	0.57	−1.17 ± 0.25	−0.66 ± 0.26	−0.95 ± 0.28	0.37
Last month of treatment	−0.83 ± 0.31	−0.93 ± 0.31	−0.97 ± 0.31	0.95	−1.03 ± 0.35	−0.90 ± 0.36	−1.27 ± 0.39	0.77
3 months after treatment	−0.94 ± 0.28	−0.98 ± 0.28	−0.68 ± 0.28	0.71	−1.15 ± 0.31	−0.87 ± 0.32	−0.87 ± 0.34	0.78
6 months after treatment	−0.95 ± 0.27	−0.86 ± 0.27	−0.73 ± 0.27	0.85	−1.15 ± 0.30	−0.80 ± 0.31	−0.96 ± 0.34	0.72
Migraine days (n/month)
Treatment period	−1.40 ± 0.43	−1.15 ± 0.43	−1.49 ± 0.43	0.85	−1.57 ± 0.60	−1.89 ± 0.58	−3.15 ± 0.63	0.16
Last month of treatment	−1.32 ± 0.55	−1.98 ± 0.55	−2.13 ± 0.54	0.54	−1.65 ± 0.44	−1.06 ± 0.45	−2.18 ± 0.49	0.25
3 months after treatment	−1.47 ± 0.55	−2.23 ± 0.55	−2.08 ± 0.54	0.59	−1.75 ± 0.57	−2.14 ± 0.58	−3.05 ± 0.63	0.31
6 months after treatment	−1.83 ± 0.52	−1.71 ± 0.52	−1.98 ± 0.51	0.93	−2.17 ± 0.53	−2.03 ± 0.54	−2.86 ± 0.59	0.55
Mean pain intensity (VAS 0–100)
Treatment period	−3.1 ± 2.3	−4.7 ± 2.3	−11.1 ± 2.3	0.04a	−3.6 ± 2.6	−5.1 ± 2.7	−14.9 ± 2.9	0.01a
Last month of treatment	−6.2 ± 3.2	⊟8.8 ± 3.2	−14.5 ± 3.2	0.18	−7.1 ± 3.7	−10.2 ± 3.7	−20.0 ± 4.1	0.06
3 months after treatment	−5.1 ± 3.5	−7.1 ± 3.5	−13.7 ± 3.4	0.19	−5.9 ± 4.0	−8.0 ± 4.1	−18.7 ± 4.5	0.09
6 months after treatment	−4.6 ± 3.6	−5.9 ± 3.6	−11.3 ± 3.5	0.37	−5.3 ± 4.2	−7.3 ± 4.3	−15.2 ± 4.7	0.27
Acute medication use (doses/month)
Treatment period	−1.33 ± 0.54	−1.08 ± 0.56	−1.89 ± 0.54	0.57	−1.84 ± 0.77	−2.43 ± 0.82	−2.94 ± 0.88	0.64
Last month of treatment	−1.56 ± 0.65	−1.98 ± 0.68	−2.15 ± 0.65	0.81	−1.59 ± 0.64	−1.49 ± 0.68	−2.54 ± 0.73	0.52
3 months after treatment	−2.84 ± 0.54	−2.72 ± 0.55	−2.71 ± 0.54	0.98	−3.34 ± 0.59	−3.10 ± 0.63	−3.63 ± 0.68	0.85
6 months after treatment	−2.91 ± 0.52	−2.30 ± 0.53	−3.64 ± 0.52	0.20	−3.42 ± 0.54	−2.97 ± 0.57	−5.02 ± 0.62	0.05 a
Quality of life (points 1–100)
After treatment	3.4 ± 1.9	5.7 ± 1.9	1.9 ± 1.9	0.37	4.3 ± 2.2	5.8 ± 2.2	2.9 ± 2.4	0.68
3 months after treatment	3.1 ± 2.4	5.0 ± 2.3	2.4 ± 2.3	0.73	4.0 ± 2.7	4.9 ± 2.7	3.7 ± 3.0	0.95
6 months after treatment	4.0 ± 2.2	5.5 ± 2.2	2.5 ± 2.2	0.62	4.9 ± 2.6	5.1 ± 2.6	3.7 ± 2.8	0.93
Level of physical activity (MET-minutes/week)
After treatment	0 (−453 to 480)	277 (0–1107)	0 (0–403)	0.23	20 (−480 to 480)	318 (0–1080)	132 (0–633)	0.34
Sedentary (hours/day)
After treatment	0 (−2 to 0)	0 (−2 to 0)	0 (0–0)	0.20	0 (−2 to 0)	0 (−2 to 0)	0 (0–1)	0.32
Oxygen uptake (ml/kg/min)
After treatment	1.1 ± 1.0	3.9 ± 0.9	−0.4 ± 1.0	0.008a	0.9 ± 1.0	4.8 ± 1.2	−0.8 ± 1.2	0.002a

Values are least square means ± standard error or median (interquartile range). ^aSignificant result.