TABLE 5.
Final simple model for the relation between average Cmax over 52 Weeks and percentage change from baseline in coronary artery calcium volume score.
| Source | DF | Sum of squares | Mean squares | F-value | p-value |
|---|---|---|---|---|---|
| Model | 3 | 0.7 | 0.2 | 9.10 | <0.001 |
| Error | 53 | 1.4 | 0.0 | — | — |
| Uncorrected total | 56 | 2.2 | — | — | — |
| Parameter | Estimate | SE | 95% CI | t-value | p-value |
| Emax, % CAC change | −14.5 | 4.7 | −22.0, −6.19 | −3.39 | 0.001 |
| E0, % CAC change | 16.9 | 4.7 | 6.6, 28.2 | −3.39 | 0.001 |
| EC50, µM | 12.2 | 12.1 | −12.1, 36.5 | 1.01 | 0.319 |
| EC80, µM | 48.7 | — | −48.4, 145.9 | — | — |
CAC, coronary artery calcium volume; DF, degrees of freedom; Emax, estimated maximum effect; E0, estimated minimum effect; EC50, hexasodium fytate concentration associated with 50% maximum effect; EC80, hexasodium fytate concentration associated with 80% maximum effect. In this model, E0 represents the percent progression of CAC, score in the absence of treatment and the Emax represents the maximum percent progression of CAC, that can be attenuated by the treatment with hexasodium fytate.
Values below the limit of quantification (LQ) were set to LQ/2 (0.379 µM).