Randomisation, blinding, use of placebo, definite inclusion/exclusion criteria and primary/secondary end points, along with the extended study period, allowed for an appropriate overview of safety and efficacy.
8 Excluding the cases in which FISH was not succeeded in the previous series (12 cases), informed consent for this extended study was not obtained from the patients (nine cases) and the cases in which the amount of tissue left was small (28 cases), 86 cases left.
The accompanying paper presents the clinical outcome for the extended LM study.
This separate study is ongoing and the results for an extended study population will be published elsewhere.
The design effort and subsequent testing has uncovered new topics for extended study, including the possibility of lateral ionic conduction within the membrane as well as the effects of non-uniform reactant distribution.
The practice of criticism, in its inherent haste, is a short-circuiting, via imaginative sympathy, of the journey through source materials (though, of course, for an extended study they are indeed invaluable).
In practice, it may be most useful to identify a handful of traits for an extended study and therefore, in addition to saving unnecessary computational cost, the maximum number K should not be too large to facilitate biological interpretation of the findings.
For my extended study, I first eliminated big events that fell within a few days of one another.
