Table 2 Mean scores, regression coefficients, and odds ratios for primary and secondary outcomes, and responder analyses (Intention to Treat, N = 181)

GPE (success, %)

OR (95% CI)

P

  3 weeks.

30.7

14.8

3.97 (1.31 to 12.04)

0.02**

  7 weeks.

51.7

42.4

1.90 0.69 to 5.20)

0.21

  13 weeks.

60.7

57.0

1.11 (0.39 to 3.15)

0.84

  26 weeks.

57.5

59.5

0.76 (0.26 to 2.18)

0.61

  52 weeks.

64.9

56.0

1.72 (0.61to 4.88)

0.31

NDI (0–50) (M, SD)

Regression Coefficients

(95% CI)

P

  Baseline

12.5 (6.8)

11.7 (5.4)

  3 weeks.

10.5 (6.9)

10.2 (5.6)

−0.24 (−1.65 to 1.16)

0.74

  7 weeks.

7.8 (6.4)

8.1 (7.1)

−0.69 (−2.14 to 0.76)

0.35

  13 weeks.

5.9 (5.8)

5.9 (4.6)

−0.23 (−1.67 to 1.21)

0.75

  26 weeks.

5.9 (5.5)

5.6 (5.6)

0.34 (−1.11 to 1.80)

0.64

  52 weeks.

5.9 (5.7)

6.6 (6.5)

−0.82 (−2.25 to 0.61)

0.26

  Baseline

5.5 (2.0)

5.8 (1.8)

  3 weeks.

4.2 (2.3)

4.6 (2.1)

−0.27 (−0.94 to 0.40)

0.42

  7 weeks.

3.2 (2.3)

3.6 (2.4)

−0.20 (−0.87 to 0.47)

0.56

  13 weeks.

2.8 (2.5)

2.6 (2.0)

0.24 (−0.44 to 0.93)

0.49

  26 weeks.

2.9 (2.4)

2.3 (2.2)

0.78 (0.09 to 1.47)

0.03**

  52 weeks.

2.5 (2.6)

2.8 (2.6)

−1.14 (−0.82 to 0.54)

0.69

OR (95% CI)

P

  3 weeks.

31.0

20.7

2.08 (0.79 to 5.43)

0.14

  7 weeks.

56.3

52.0

1.26 (0.49 to 3.24)

0.63

  13 weeks.

66.3

65.8

0.97 (0.37 to 2.53)

0.95

  26 weeks.

62.0

69.6

0.55 (0.21 to 1.47)

0.23

  52 weeks.

60.5

63.1

0,79 (0.31 to 2.02)

0.63

  3 weeks.

34.9

37.2

0.87 (0.38 to 2.14)

0.73

  7 weeks.

55.2

56.6

0.95 (0.42 to 2.14)

0.89

  13 weeks.

59.4

65.2

0.56 (0.23 to 1.38)

0.21

  26 weeks.

58.2

79.5

0.25 (0.10 to 0.63)

0.00**

  52 weeks.

69.1

69.9

0.93 (0.39 to 2.25)

0.88