Limitations
Our study has limitations. First, the small number of patients available for analysis limits the results’ generalizability despite the randomization. Second, one of the most obvious shortcomings of this study is its potentially limited external validity derived from its single-center nature. Third, related to its low sample size, the trial certainly had a likelihood of type II error (declaring no differences between groups when, in fact, these differences exist). Thus, it could be argued that the study lacks sufficient power and should be interpreted as presenting inconclusive findings. However, we have presented the steps we followed to stop the trial, suggesting that completing the sample size would not have guaranteed reaching statistical significance.