Exact(4)
A criterion for evidence of effect based on a majority of endpoints has been accepted in other research fields.
With the approach described here, the power obtained to detect a majority of endpoints with positive trends is greater than that required for each individual endpoint.
A criterion for acceptance of proof of concept illustrated here was a simple majority of endpoints favouring the test treatment and with a positive trend at the one-sided 0.10 level.
Of the 4 doses studied, this dose group was the only group to meet the criterion of a majority of endpoints with one-sided P < 0.10 favouring relaxin compared to placebo; it had the greatest number of favourable endpoints with one-sided P < 0.10 (6 of 9), and it had no unfavourable result with a one-sided P value > 0.90.
Similar(56)
The addition of artesunate to CPG DDS demonstrated advantages over CPG DDS alone for the primary efficacy endpoint (mean time to PC90) and for the majority of secondary endpoints in the adult group.
The majority of primary endpoints yield continuous variables (e.g. CES-D summary score, systolic/diastolic blood pressure [mmHg], intima media thickness [mm]) with change over time.
Although large atherosclerotic plaques may cause a degree of stenosis and tissue ischaemia, the majority of clinical endpoints of atherosclerotic disease, such as myocardial infarction or stroke, arise from the exposure of the thrombogenic contents of atherosclerotic lesions to the circulation, thus giving rise to thrombi or emboli [2].
A possible criterion for evidence of efficacy can be based on P values from univariate pairwise comparisons of each dose with placebo for all candidate endpoints; e.g., positive 'trends' with one-sided P < 0.10 (equivalent to two-sided P < 0.20 favouring active drug) for the majority of the endpoints is applicable, and its occurrence by chance can have assessment across permutation samples.
On subgroup analysis, the majority of renal endpoint occurred in patients with accelerated decline in renal function in whom treatment with olmesartan was similar to placebo.
Further, the majority of our biomarker endpoints were only assessed within the first 24 h.
Table 2 shows this superiority pattern for the majority of the secondary endpoints.
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