Primary and secondary end-points were not pre-specified, but headache index, defined here as headache frequency × severity, was the evaluated end-point.
Compared with placebo, a greater improvement on all the evaluated end-points was reported.
This included developing an estrogen suppression target expected to provide symptomatic relief with minimal BMD loss and to evaluate end points and study durations supportive of efficient development decisions.
The objective of this study was to evaluate end points affected by DBP action in rats in fetal and adult life that are relevant to human TDS, and to compare their dose sensitivity.
Therefore, the aim of the present study was to evaluate end points in our in vivo rat model of TDS that can be related more obviously to similar TDS disorders in humans, and to explore the DBP dose sensitivity of these end points.
Although many of these trials evaluated an end point of pneumococcal pneumonia, which was variably defined depending on the trial, none identified a reduction in the risk of pneumococcal pneumonia in prespecified analyses of all subjects.
Histological specimens were first interpreted for clinical management by pathologists at a central laboratory (Diagnostic Cytology Laboratories, Indianapolis, IN, USA), and then evaluated for end point determination by a blinded panel of four pathologists.
We did not evaluate this end point but now would consider using it.
Pharmacometrics can provide the optimal way to evaluate an end point, balancing the need to be conservative but not excluding a drug with appropriate efficacy.
Workers from Australia (Audrins et al, 1999) have reported an even lower utilisation rate (7%) but in this study the mean follow-up time was only 3 years, a factor that may be important in evaluating this end point.
