Table 3.

Definition of cases and controls.

Control patients	No signs of hepatotoxicity based on laboratory measurements (stage 0). No clinical signs of hepatotoxicity (asymptomatic).
Case patients	Signs of hepatotoxicity based on laboratory measurements (stage 1–4). May or may not have clinical signs of hepatotoxicity.
Unclassified	Patients with signs of hepatotoxicity, but without clear laboratory signs of abnormal LFTs (stage 0). These patients will not be classified into case or control groups, but their samples will be used to evaluate plasma microRNA levels as biomarkers of early liver dysfunction.