Statistical analysis
The sample size was not powered for any hypothesis testing because of the limited number of enrolled patients; thus, the sample size was determined based on feasibility. All efficacy and safety analyses were conducted for the intent‐to‐treat population (all randomized patients who received one or more dose of the study drug). No patients were excluded from the analyses. In addition to the as‐observed analysis, nonresponder imputation and last‐observation‐carried‐forward analyses were used to handle missing data for binary and continuous end points, respectively.