Plateau processing starts off by finding all the current pixel neighbours of similar value and writes them to Q1. Q1 is predefined to be the first queue to be used.
The significance level for selection is predefined to be 0.15 and that for elimination is 0.2.
Therefore, equivalence margins for the difference in the number of oocytes retrieved were predefined to be −3 and +5 oocytes.
13 The number of non-severe hypoglycaemias were predefined to be evaluated both below 4.0 mmol/L (72 mg/dL) and 3.0 mmol/L (54 mg/dL).
Statistical comparisons were predefined to be done with a fixed testing sequence (hierarchical) in the following order of primary followed by secondary end points: REDUCE-1: gastric ulcers, upper GI ulcers, duodenal ulcers, GI complications; REDUCE-2: upper GI ulcers, gastric ulcers, duodenal ulcers, GI complications.
How the change is implemented, the checklist and steps, are predefined and were presented to and approved by the CAB.
Intraocular pressure changes of less than 4 mm Hg from baseline to week 12 were predefined as being clinically not significant.
During the study, the dose modification criteria were predefined and were based on toxicities.
This cut-off is predefined and is based on previous research [ 6, 8, 12].
Dropping out was predefined as being absent from five consecutive sessions or from 20% of all sessions.
