Fig. 1
Pathway to intended efficacy outcomes from dsxFCRISPRh transgenic releases. Potential factors that could inhibit steps in the efficacy pathway, the point at which they could occur, analysis plan to detect the presence of such factors and branch points from intended efficacy outcomes for individual potential harms. For each pathway to harm in this study, the first stages of the pathway involving intended efficacy outcomes are illustrated in dark blue, with subsequent steps in the pathway specific to the occurrence of that harm are shown in lighter blue. Third to last potential factor inhibiting intended efficacy outcomes is addressed via Pathways 7, 27, 29, 43 and 45 (see Figs. 9, 29, 45 and 47, respectively). Second last potential factor inhibiting intended efficacy outcomes would be assessed in analysis plan of Pathway 20 via modelling. Last potential factor inhibiting intended efficacy outcomes could occur in the absence of the intervention and thus “will do no more harm to human health than wild-type mosquitoes” [30]. Analysis plan represents data gathering pre-release only. Further assessments and field monitoring would accompany field releases but be addressed in subsequent risk management stages of the ERA