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In the Phase 3 and A3921041 LTE studies, patients discontinued therapy if two sequential increases in SCr >50% over baseline values were reported.
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Baseline values are reported as means ± standard deviation (SD).
Baseline values are reported as mean ± standard deviation; and non-normally distributed data reported as median (range).
When no baseline value was reported, as in some crossover studies, we summarized the intervention effect by the ratio of the difference in final values between LFHC- and HFLC-diet groups to the final value in the HFLC-diet group and assumed that the baseline SE was equal to the final SE.
Adult values were reported at baseline and follow-up.
Predicted values were reported as a percent change compared with baseline values for each categorical variable in the regression.
Baseline lipoprotein concentration values are reported as those measured in plasma and the subsequent two samples in a trial were corrected for estimated changes in plasma volume from baseline using hematocrit (van Beaumont 1973).
Baseline PBPK model parameters values are reported in Tables 1 and 2. Some parameters were treated as random variables and assigned statistical distributions as explained below, but their sampling distributions stayed centered on their baseline values.
* Initial [TC]: mean concentration of total cholesterol, in mmol/L, at baseline Dispersion information around reported mean values was reported sporadically.
It is disappointing that glycosylated hemoglobin values are reported only at baseline.
Baseline characteristics of the 1,825 recruited patients by quartiles of NT-proBNP values are reported in Table 1.
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