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Fortunately, the study still met its prespecified objective.
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As well as committing to publication within a year, restorative authors must adhere to the study protocol and its prespecified objectives, as well as to other reporting standards.
Recent trials [ 3- 7] have reported that as-needed ranibizumab injections based on monthly examinations could be effective if patients strictly adhered to the prespecified objective treatment criteria, which requires intensive long-term follow-up.
Specifically, the prespecified objectives were to test potential treatment benefits from intensive glycemic versus standard therapy in terms of less symptom distress, improved general health (physical and psychological wellbeing), and improved treatment satisfaction.
The study met its prespecified primary endpoint.
The trial did not meet its prespecified primary end point of >60% patients progression free at 6 mo.
It was used by Koyama and Chen [ 11] when n2 is different from its prespecified value, and will thus be denoted by Π ^ k, although they used Π ^ w in their article when n2 was as planned.
10, 11 The early findings from the CORRECT trial show that regorafenib provided statistically significant benefits in overall survival (OS) and progression-free survival (PFS) meeting its prespecified stopping criteria for efficacy.
Of important note is that CAROLINA is the only study that designated in its prespecified inclusion criteria patients with prevalent microvascular complications, such as chronic kidney disease and/or microalbuminuria.
The strengths of this study include complete long follow-up, contemporary path review of Gleason grade, a definitive end point (10-year mortality from prostate cancer) and a completely independent validation cohort with fully prespecified objective end points and prespecified analysis algorithms.
Yet it achieves its objective.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com