Reporting
Frequent reporting on the progress of the trial was critical to identify early evidence of efficacy, if present. To that aim, the reports contained graphical and tabular exploration of the data without formal interim statistical testing. To limit the time between data transfer and distributing data reports, the pharmacometric processing script was developed to automatically generate reproducible data reports. RMarkdown was used to incorporate R-based output (numeric, graphical, tabular) with written text, which was compiled into a pdf document by knitr (v.1.33