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In both budesonide groups, FEV1 deteriorated significantly (P<0·01 and P<0·02, respectively) after termination of study medication and reached pretreatment values during the first month.
The standard necropsies procedures were carried out at the termination of study to collect the required tissues and blood sample for various analyses from mice of both sexes, as the study does not involve any gender specific parameters.
For long-term disease outcome studies, groups of eight guinea pigs were set up as exactly as for the above short-term studies except that the guinea pigs were not euthanized at 40 days post-M.tb challenge and were euthanized only when they reached the clinical disease endpoint or at the termination of study at 74 weeks post-challenge (Fig. 1B diagram).
The most common reason for termination of study treatment was radiologically confirmed disease progression.
Among those, 40 patients were dead and 57 patients were alive until the termination of study.
Early termination of study in response to safety issues will be addressed via the DMC.
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Although the target sample size was achieved, an independent data-monitoring committee recommended early termination of study-drug administration because of an interim analysis that indicated higher mortality in the ESA arm.
Termination of studies at the earliest possible point will minimise adverse effects on the animal.
Student numbers varied from one year to the next, due, for example, to termination of studies, withdrawal for health reasons, etc.
In addition to conducting studies that did not use placebo controls, other compromises included the use of surrogate endpoints, such as reduced CD4 counts, and early termination of studies based on preliminary data [ 56, 57].
After termination of the study, patients in both study groups will receive written information concerning the complete research question by means of a letter.
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