Table 2.
Week 6 | Week 12 | ||||||
Endpoint | Baseline Score | change from baseline | p value (between groups) | change from baseline | p value (between groups) | Total Treatment p value | |
Physiological | |||||||
Mg2 + Urine (mg/ml) | |||||||
MMFS-01 | 0.061 ± 0.003 | 0.026 ± 0.007 | 0.140 | 0.025 ± 0.007 | 0.048* | 0.027* | |
Placebo | 0.062 ± 0.006 | 0.012 ± 0.006 | 0.005 ± 0.007 | ||||
[Mg2 +] Plasma (mg/dL) | |||||||
MMFS-01 | 2.04 ± 0.033 | 0.100 ± 0.032 | 0.026* | 0.065 ± 0.030 | 0.808 | 0.119 | |
Placebo | 2.06 ± 0.041 | –0.002 ± 0.043 | 0.052 ± 0.035 | ||||
[Mg2 +]i RBC (mg/1011 cells) | |||||||
MMFS-01 | 1.15 ± 0.038 | 0.003 ± 0.026 | 0.217 | 0.032 ± 0.023 | 0.262 | 0.829 | |
Placebo | 1.19 ± 0.035 | 0.049 ± 0.026 | –0.009 ± 0.021 |
Mean ± SEM. *significant p < 0.05.