Statistical analysis
autoimmune encephalitis
AUTOIMMUNE ENCEPHALITIS
A sample size of 308 participants recruited over a 24-month period (154 per group, with approximate 10% attrition rate) was planned to achieve 90% power (at 5% level of significance) to detect at least a 20% clinically significant treatment difference from 43% in the ‘good recovery’ rate (defined as a GOS-E Peds score of ≤2) by 12 months after randomisation. This was based on the results of a large observational study on autoimmune encephalitis.At the time the trial was halted, only 18 participants had been recruited. The trial was therefore underpowered to perform hypothesis testing of outcomes, subgroup comparisons or sensitivity analyses. Therefore, all analyses performed were descriptive. The analyses were performed on the intention-to-treat population; this included all 18 participants who were randomised. In the analysis of the AEs, the population analysed were the 16 participants who received study treatment.