Composition of the data monitoring committee, its role and reporting structure {21a}
hepatic injury
LIVER CIRRHOSIS
A data monitoring committee has been established to periodically evaluate the available accrued trial data (including unblinded safety data, efficacy data, results of interim analyses for the 1366.0021 trial, final results of the 1366.0029 trial, significant safety concerns and decisions from hepatic injury adjudication) and to recommend to the sponsor the continuation, modification or termination of the trial. The data monitoring committee is independent from BI and includes a statistician and physicians experienced in the treatment of liver cirrhosis. Regular committee meetings will be held quarterly. Details of the data monitoring committee’s responsibilities and procedures are available in the prespecified data monitoring committee charter. The primary role of the data monitoring committee is the ongoing evaluation of safety.