Main Trial Transition

The main trial uses Bayesian analyses with non-informative priors and prespecified superiority or futility thresholds. The vanguard phase confirmed overall feasibility and BALANCE+ transitioned to the full platform trial. The catheter and AmpC domains were retained despite low recruitment because no competing randomized controlled trials existed. Additional yearly time-based interim analyses were added for the catheter and AmpC domains, with possible removal if recruitment stays insufficient. Vanguard patients were included in the main trial because protocol changes were minimal.