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. 2022 Mar 28;28(4):780–788. doi: 10.1038/s41591-022-01737-y

Extended Data Table 1.

Summary of protocol phases/versions and amendments submitted to FDA and oversight committees

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B-VEC has been administered to nine (9) patients, in twelve (12)a siloed participant treatment applications. Patients (IDs: Pts 1-12)a enrolled separately onto one of 4 versions of the Phase 1 and 2 protocol. A summary of the protocols and patients enrolled are presented below. aThree patients were enrolled into both Phase 2a and Phase 2b. These patients’ Phase 2b wounds were treatment-naïve except for a chronic (5 year) dorsal foot wound on Pt 3. A wash-out period of 3 months passed between treatments in Phase 2a and 2b. Patients were enrolled in Phase 2a as Pts 3, 5, and 6 and in Phase 2b as Pts 11, 8, and 7, respectively. Pts # refer to patient identification numbers 1-12, nine total patients enrolled, three enrolled in both 2a and 2b with unique identification number. bProtocol versions represent intended design which was amended in consultation and with approval from oversight committees and regulatory authorities; protocol amendments correspond to Phases (1, 2a, 2b, 2c). *v3.2 clarified the long-term follow-up. B-VEC, beremagene geperpavec; Pt, Patient.