Based on previous non-GLP-1 pharmaceutical trials in NASH utilising improvements in liver histology as a primary endpoint, 41 42 it was assumed that 14 17% of patients undergoing current standard of care (placebo) would have an improvement in NASH by week 48.
The diagnosis of cardiac disease (Table 1) was based on previous history (non-acute) in seven out of nine patients.
The depth of sequencing chosen for this study was based on previous experience sequencing non-normalized cDNA libraries [ 38].
The range of PBA and TUDCA doses used in this study is based on previous studies in non-steatotic livers undergoing I/R without hepatectomy.
This was based on previous works performed in non-cancer critically ill patients and cancer patients with septic shock, for whom trends in organ failures during the first 3 days in the ICU were found accurate predictors of outcome as compared to single assessment on admission [16 18, 8].
The study combined actual pharmacy claims data with general assumptions based on previous studies of different non-adherence rates for patients in different age groups, drug therapies, and with a varying number of dispensed drugs.
This was based on previous works performed in non-cancer critically ill patients and cancer patients with septic shock, for whom trends in organ failures during the first 3 days in the ICU were found accurate predictors of outcome as compared to single assessment on admission [ 16– 18] 8].
The outcome measure used to calculate sample size will be the change in HbA1c level from baseline to month 12. Based on previous work, in a non-randomised comparison of HbA1c levels over time in type 1 diabetes patients with asymptomatic CD who received a GFD versus patients with type 1 diabetes alone, an increase in HbA1c of 8.3±1.1% to 8.9±1.5% was observed.
The developed analytical closed-form solution is based on previous solutions, initially developed for non-encased columns and for non-dilating rigid-plastic column material.
We designed a generic one-week EBM course based on previous experience with EBM courses for non-medical health professionals.
Based on previous reports, the number of non-collinear gradients applied varies (ranging from 6 to 55) however an optimal number has not been defined [ 33- 35].
