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Box 26 Exemplar on reporting item 21 elements

From: The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Example 1. Bayesian population-enrichment AD with RAR; to whom the results are applicable (full population)
“The DAWN trial showed that, among patients with stroke due to occlusion of the intracranial internal carotid artery or proximal middle cerebral artery who had last been known to be well 6 to 24 h earlier and who had a mismatch between the severity of the clinical deficit and the infarct volume, outcomes for disability and functional independence at 90 days were better with thrombectomy plus standard medical care than with standard medical care alone.” [96]
Example 2. Phase 2 Bayesian biomarker-targeted AD with RAR; to whom the results are applicable (biomarker specific)
“Sorafenib was active against tumors with mutated or wild-type KRAS, but had a worse disease control rate (compared with other study agents) in patients with EGFR mutations. As expected (5–7, 15–17), erlotinib was beneficial in patients with mutated-EGFR tumors. Erlotinib plus bexarotene improved disease control in patients with a higher expression of Cyclin D1, suggesting a potential role for bexarotene in lung cancer treatment (11); similar to sorafenib, the combination also improved disease control in the KRAS-mutant patient population. Future randomized, controlled studies are needed to further confirm the predictive value of these biomarkers.” [256] Liu and Lee [81] published details of the design and conduct of this trial.