Procedure for unblinding if needed {17b}
Unblinding will occur in the case of participant emergencies and after the data analysis. It is the principal investigator’s responsibility to maintain blinding at the clinic site.If needed to ensure adequate treatment where the principal investigator deems identification of the study drug necessary, the principal investigator or delegate can perform unblinding. The clinical research unit, having a list of patients containing their patient number, rank, and assigned group, may provide emergency disclosure of unblinding information to the Investigator. In this case, the circumstances surrounding the breaking of the blinding code will require documentation. The Investigator should determine and document “causality” prior to unblinding the study drug.This assignment will be revealed to the principal investigator and the study team after the statistical tests have been carried out and the results obtained.