Statistical analyses
To ensure an efficient adaptive trial design, Bayesian statistics were used. In part 1 of the trial, a dose of 3 mg kgECG parameters were analyzed based on a linear mixed-effects model; a least squares mean with 90% CIs was reported for these.The safety analysis set was prespecified to be used for all safety analyses and consisted of all randomized participants who were administered double-blind trial treatment. The full analysis set was prespecified to be the primary one for all efficacy analyses and consisted of all randomized participants who were administered double-blind trial treatment and had an evaluable AF conversion status within 90 min from the start of the infusion.The sample size was selected based on a similar previous trialData analyses were done by the contract research organization Syneos Health and by the sponsor. All authors had access to the data. SAS v.9.4 or higher and R v.3.5.2 or higher were used for the analyses. Data were collected through the electronic data capture system Medidata Classic Rave (2019–2023).