Table 3.
Linear Mixed-Effects Model-Based Differences in Safety Outcomes of Treatment Compared to Baseline and Difference Between Groups*
| Continuous | Cyclic | Difference (Continuous-Cyclic) |
||||
|---|---|---|---|---|---|---|
| Mean Change (95% CI) |
P | Mean Change (95% CI) |
P | Mean Change (95% CI) |
P | |
| Weight (kg) | 2.1 (1.1,3.1) | <.001 | -0.2 (-1.3,0.8) | 0.67 | 2.3 (0.8,3.8) | 0.003 |
| BMI (kg/m2) | 0.8 (0.4,1.1) | <.001 | 0.0 (-0.4,0.4) | 0.92 | 0.7 (0.2,1.3) | 0.01 |
| Systolic blood pressure (mm Hg) | 2.4 (-2.8,7.6) | 0.35 | 10.5 (5.1,15.8) | <.001 | -8.1 (-15.5,-0.6) | 0.04 |
| Diastolic blood pressure (mm Hg) | 3.1 (-2.6,8.9) | 0.27 | 11.0 (5.1,16.9) | <.001 | -7.9 (-16.1,0.4) | 0.06 |
| Alkaline phosphatase (J/L) | -9.3 (-17.1,-1.5) | 0.02 | -7.6 (-15.9,0.7) | 0.07 | -1.7 (-13.1,9.7) | 0.76 |
| ALT (J/L) | 2.8 (0.0,5.6) | 0.05 | 1.7 (-1.5,4.8) | 0.28 | 1.2 (-3.0,5.4) | 0.57 |
| Total cholesterol (nmol/L) | 0.4 (0.2,0.7) | 0.003 | 0.4 (0.1,0.7) | 0.007 | 0.0 (-0.4,0.4) | 0.96 |
| HDL (nmol/L) | 0.2 (0.0,0.3) | 0.05 | 0.2 (0.1,0.4) | 0.007 | -0.1 (-0.3,0.1) | 0.45 |
| Triglycerides (nmol/L) | 0.3 (0.1,0.5) | 0.006 | 0.2 (-0.0,0.4) | 0.07 | 0.1 (-0.2,0.4) | 0.49 |
*
Only parameters with a significant difference compared to baseline or between groups. BMI, body mass index; ALT, alanine transminase; HDL, high-density lipoprotein.