In line with the clinical evaluation, the provision of estimates for the cost-effectiveness of stratified primary care management within each risk-defined subgroup was a prespecified analysis.
The results from the dyslipidemic subgroup in the ACCORD Lipid trial, which was a prespecified analysis, are similar to post hoc analyses performed in prior fibrate studies, including the Helsinki Heart Study (12), the Bezafibrate Infarction Prevention (BIP) trial (13), and FIELD (14).
A statistical comparison of CGI –S shifts associated with LDX and ATX treatment was not a prespecified analysis and p-values comparing the effects of each treatment on CGI –S shifts were not generated.
Central HER2 testing of tissue samples to examine discordance was not a prespecified analysis.
The present study on attendance in relation to annual milestones was not a prespecified analysis of the trial.
Although the primary outcome of hospital length of stay was negative, a prespecified analysis of patients with severe vitamin D deficiency, defined as 25D levels ≤12 ng/ml, found an almost 50% reduction in hospital mortality in the active treatment group compared to placebo.
The type of intervention (pharmacological versus non-pharmacological) was a prespecified subgroup analysis.
This study was a prespecified approved analysis project within the Infections in Oxfordshire Research Database, an anonymised linked electronic database including microbiology and patient data from Oxfordshire, approved by the Oxford Research Ethics Committee and the National Information Governance Board.
This was a prespecified secondary analysis among 942 hyperlipidemic patients randomized to ezetimibe/simvastatin (E/S; 10/20 mg) or E/S + extended-release niacin (N; titrated to 2 g) over 64 weeks.
Analysis will be conducted according to a prespecified analysis plan.
