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For the KMIS there were also a few noted trends with one of the comparator studies.
The comparator studies only described outcomes in patients who had undergone two-stage open surgical repair with vascular graft replacement [ 28– 31].
The comparator studies were all conducted between 1990 and 2006, and therefore most of the evidence preceded establishment of the E-vita open registry.
Of the comparator studies reporting the effect of FFP on blood loss, one reported lower blood loss as a result of FFP [ 34].
The EAC noted that the comparator studies mostly preceded the E-vita open plus studies according to their date of publication and, furthermore, the comparator studies were all conducted in the US whereas the E-vita open plus studies were all conducted in Europe.
From the baseline patient information presented in the papers, there was no reason to suspect that the patient populations in the E-vita open plus studies were markedly different from those included in the comparator studies.
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The comparator study did not report this outcome [ 20].
It was unclear how the sponsor had selected the comparator study [ 20].
The comparator study test throughout the study was Abbott Determine™ HIV-1/2 (Inverness Medical, reported specificity 99.6%, sensitivity 99.4% [ 19]).
However, the comparator study from Bruni et al. [ 31] only included women with normal cytology whereas the cytology status was not known in the present study [ 32].
The comparator study selected by the sponsor evaluated the clinical and radiographic complications associated with growth rod treatment and was not an efficacy study.
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