HOPE-2 enrolled 20 participants rather than the original target of 84; an amended protocol limited enrollment to 20. Allocation was 8 to CAP-1002 and 12 to placebo, and the FDA primary efficacy analysis included 19 participants. The publication reported a significant percentile-rank result, whereas FDA’s original-scale analysis had a confidence interval crossing zero and a nominal p value of 0.13. FDA identified changes to the statistical plan after unblinding. The SAP described subsequent efficacy p values as nominal. The abstract and full-text results report different confidence intervals for the percentile difference. The small sample, incomplete follow-up, and disagreement between analyses limit precision and confidence in the treatment-effect estimate.