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CONSORT diagram for the PHOCUS study. The intent-to-treat (ITT) population included all patients randomly assigned to study treatment. The per-protocol (PP) population included all patients from the ITT population without any major protocol deviations who had completed the minimum exposure requirement. Minimum exposure requirements were ≥1 pexa-vec injection in the pexa-vec plus sorafenib arm and ≥2 consecutive weeks of sorafenib treatment in the sorafenib arm.
