Design, quantification, and statistical analysis
The original sample size target of 42 was based on an A’Herns design and power of 80%. An alternative approach adopted a Bayesian framework to adjust to the total 38 patients recruited. A beta-binomial conjugate analysis confirmed an equal probability with the original A’Herns design and the Bayesian framework considering the 38 patients recruited and concluded that the primary outcome would need to be observed in at least 3 patients to meet the success criteria. The primary endpoint was a reduction in the peripheral blood 