Figure 1

Simplified version of a graph for comparative assessment showing the seven outcome types possible for each characteristic analysed. After adjustment of the equivalence limits, a single confidence limit (for the difference) serves visually for assessing the outcome of both difference and equivalence tests. Here, only the upper adjusted equivalence limit is considered. Shown are: the mean of the GMO compared to the mean of the counterpart on an appropriate scale (square), its confidence interval (bar), a thick vertical line indicating zero difference (for proof of difference), and thinner vertical lines indicating adjusted equivalence limits on the same scale (for proof of equivalence). For outcome types 1, 3 and 5 the null hypothesis of no difference cannot be rejected: for outcomes 2, 4, 6 and 7 the GMO is different from its counterpart. Regarding interpretation of equivalence, four categories (i) - (iv) are identified: in categories (i) and (iv) there is a significant equivalence and non-equivalence, respectively, in categories (ii) and (iii) equivalence and non-equivalence, respectively, are more likely than not.