IL-10 (pg/ml)

Intention-to-treat analysis

Baseline (63 vs. 59)

9.43 (8.85)

9.09 (12.56)

0.34 (−3.59 to 4.26)

0.101

12-week (43 vs. 42)

8.05 (9.13)

5.74 (8.10)

2.31 (−1.41 to 6.04)

0.016

24-week (28 vs. 27)

6.23 (5.34)

4.91 (8.62)

1.32 (−2.59 to 5.24)

0.012

Per-protocol analysis

Baseline (45 vs. 43)

8.71 (8.73)

7.70 (11.18)

1.01 (−3.23 to 5.25)

0.209

12-week (40 vs. 38)

8.12 (9.42)

6.13 (8.41)

1.99 (−2.05 to 6.03)

0.038

24-week (26 vs. 24)

6.16 (5.49)

5.29 (9.09)

0.87 (−3.47 to 5.22)

0.023

STRESS HORMONES

Cortisol (mg/L creatinine)

Intention-to-treat analysis

Baseline (62 vs. 62)

35.50 (19.56)

32.70 (17.45)

2.80 (−3.79 to 9.39)

0.379

12 weeks (46 vs. 42)

31.15 (19.63)

30.56 (18.42)

0.59 (−7.50 to 8.68)

0.937

24 weeks (28 vs. 27)

23.19 (9.09)

28.60 (27.36)

−5.41 (−16.70 to 5.88)

0.959

Per-protocol analysis

Baseline (43 vs. 46)

35.90 (20.62)

31.43 (17.07)

4.47 (−3.49 to 12.42)

0.293

12 weeks (44 vs. 38)

30.41 (19.07)

31.24 (18.87)

−0.83 (−9.19 to 7.54)

0.821

24 weeks (26 vs. 23)

23.99 ( 8.94)

30.66 (29.16)

−6.67 (−19.68 to 6.35)

0.986

Epinephrine (mg/L creatinine)

Intention-to-treat analysis

Baseline (62 vs. 63)

12.22 (20.95)

10.29 (17.57)

1.93 (−4.89 to 8.75)

0.576

12 weeks (44 vs. 43)

5.73 (5.55)

5.28 (4.22)

0.45 (−1.65 to 2.56)

0.779

24 weeks (30 vs. 27)

5.55 (4.49)

3.67 (3.15)

1.88 (−0.20 to 3.96)

0.067

Per-protocol analysis

Baseline (46 vs. 46)

12.58 (22.24)

10.86 (19.92)

1.72 (−7.03 to 10.46)

0.87

12 weeks (42 vs. 39)

5.75 (5.66)

5.13 (4.06)

0.63 (−1.55 to 2.79)

0.273

24 weeks (28 vs. 23)

5.35 (4.23)

3.90 (3.17)

1.45 (−0.69 to 3.60)

0.098

Norepinephrine (mg/L creatinine)

Intention-to-treat analysis

Baseline (61 vs. 62)

52.20 (42.08)

50.08 (28.79)

2.12 (−10.79 to 15.03)

0.85

12 weeks (46 vs. 41)

60.85 (44.05)

52.01 (35.07)

8.83 (−8.28 to 25.95)

0.748

24 weeks (30 vs. 27)

52.04 (35.50)

43.87 (34.52)

8.17 (−10.46 to 26.80)

0.198

Per-protocol analysis

Baseline (44 vs. 45)

56.44 (47.59)

53.29 (31.47)

3.15 (−13.93 to 20.23)

0.715

12 weeks (44 vs. 37)

61.49 (44.64)

51.31 (32.35)

10.18 (−7.36 to 27.73)

0.76

24 weeks (28 vs. 23)

53.93 (35.94)

45.11 (35.42)

8.81 (−11.38 to 29.01)

0.197