Table 2.
Test Group | Within Group Analysis of Test Group | Placebo Group | P➔T ** | Within Group Analysis | Between Group Analysis | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Crossover Group | Placebo Group | P➔T ** Crossover Group | ||||||||||||||||
Day 0 | Day 30 | Day 60 | Day 0–30 | Day 30–60 | Day 0–60 | Day 0 | Day 30 | Day 60 | Day 0–30 | Day 30–60 | Day 0 | Day 30 | ||||||
Mean ± SE | Mean ± SE | Mean ± SE | % Change | p Value # | % Change | p Value # | % Change | p Value # | Mean ± SE | Mean ± SE | Mean ± SE | % Change | p Value # | % Change | p Value # | p Value $ | p Value $ | |
IgA | 170.06 ± 16.99 | 180.2 ± 18.28 | 184.13 ± 18.66 | 5.96 | <0.001 | 2.18 | <0.001 | 8.27 | <0.001 | 169.9 ± 14.95 | 174.88 ± 15.76 | 183.62 ± 16.55 | 2.93 | 0.764 | 5 | <0.001 | 0.994 | 0.828 |
IgG2 | 212.16 ± 16.4 | 217.5 ± 16.71 | 224.69 ± 17.25 | 2.52 | <0.001 | 3.31 | <0.001 | 5.91 | <0.001 | 205.97 ± 21.36 | 183.74 ± 15.4 | 189.25 ± 15.86 | −10.79 | 0.286 | 3 | <0.001 | 0.82 | 0.151 |
IgG3 | 47.63 ± 3.72 | 48.83 ± 3.81 | 50.87 ± 3.97 | 2.52 | <0.001 | 4.18 | <0.001 | 6.8 | <0.001 | 43.03 ± 3.5 | 50.36 ± 5.38 | 50.76 ± 5.42 | 17.03 | 0.172 | 0.79 | <0.001 | 0.377 | 0.819 |
IgG4 | 24.96 ± 2.64 | 25.97 ± 2.76 | 27.37 ± 2.90 | 4.05 | <0.001 | 5.39 | <0.001 | 9.66 | <0.001 | 24.95 ± 2.67 | 26.42 ± 2.47 | 26.95 ± 2.52 | 5.89 | 0.704 | 2.01 | <0.001 | 0.997 | 0.906 |
IgG | 801.44 ± 59.19 | 842.23 ± 62.2 | 894.14 ± 66.12 | 5.09 | <0.001 | 6.16 | <0.001 | 11.57 | <0.001 | 822.99 ± 69.52 | 836.58 ± 70.88 | 881.75 ± 74.71 | 1.65 | 0.879 | 5.4 | <0.001 | 0.816 | 0.953 |
IgM | 183.9 ± 34.41 | 185.43 ± 34.67 | 200.7 ± 37.54 | 0.83 | <0.001 | 8.23 | <0.001 | 9.14 | <0.001 | 184.14 ± 55.64 | 185.17 ± 55.97 | 186.41 ± 56.34 | 0.56 | 0.99 | 0.67 | 0.002 * | 0.997 | 0.299 * |
# Within group significance using the t-test (equal variances). $ Between the group significance using the t-test for independent groups. * p value using Mann–Whitney test. P➔T ** Placebo group crossed over to the test group in the extension study period.