Limitations
The extension phase of the DELIVER trial lacked a placebo or active comparator arm, which may limit the interpretation of the results; however, dose-blinding was maintained for patients and investigators (but not for the sponsor) throughout the extension phase. Although the study was primarily conducted in Europe, the results are likely applicable to the US. Enrolled patients were predominantly White and female, limiting generalizability. Additional studies in broader patient populations are needed to confirm that observed benefits extend to these populations. DELIVER did, however, include older participants (up to and including 75 years of age) and those with comorbidities that were excluded in previous trials. The inclusion of these patients did not appear to be associated with any new safety concerns. Lastly, DELIVER did not allow for dose escalation or reduction; thus, the effects of changing dose levels during long-term treatment cannot be evaluated.