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Each of the endpoint assays would have required us to set up an entirely separate screen at each time point as these assays are lytic or toxic to the cells.
Four group pairs were compared with each other: control GMO 11%%, control GMO 33%%, control conventional 1 and control conventional 2. The SES estimates are shown as graphs, displaying both the statistical significance and the supposed biological and possible toxicological relevance limits for each of the endpoint comparison results.
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Response-surface analysis was applied to each of the endpoints.
Finally, a point estimate can also be calculated, which combines the bioavailability related to each of the endpoints studied simultaneously, and is weighted according to its uncertainty.
Within- and between-subject variability to the technique was assessed by measuring the maximum recorded values (max), time to maximum value (tmax) and area under the curve (AUC(0 1 h)) of each of the endpoints.
In addition, each of the endpoints at week 4 (including ESR and CRP) was analyzed using a repeated measure analysis of covariance model (ANCOVA).
Cox regression was used to estimate the prospective association of these variables with each of the endpoints (death, myocardial infarction, and recurrent ischemia requiring revascularization), as well as the combined endpoint after 5-year follow-up.
When the repeated measure ANCOVA was applied for each of the endpoints at week 4, the effect of active treatment was significant for the reduction of ESR (P = 0.001), CRP (P = 0.01), and serum MMP-3 (P = 0.006), as well as for the increase of serum MIA level (P = 0.013), indicating that these biomarkers could distinguish between effective and ineffective treatment (Table S3).
The hazard ratio (HR) with 95%% confidence interval were reported for each of the endpoints.
The predictive power of the biomarker panels was stronger than for CRP alone for each of the endpoints.
Missing data resulting from the missing CRFs or missing CRF pages in this study are reported for each of the endpoints in the relevant sections or tables.
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