5.3.2 Risk Benefit Assessment The reported data suggest a safe pharmacological profile apart from individual cases of hepatotoxicity which can be controlled for by routine serum liver parameters. The preclinical data suggest a molecular mode of action for EGCG which appears to target core pathological mechanisms active in MSA. In absence of any effective symptomatic, protective or curative intervention in this devastating disorder, the risk benefit evaluation justifies the conduct of the proposed clinical trial.