Table 2 Study exclusion criteria

• Female patient of childbearing potential who is unwilling to use effective means of contraception

• Increased liver enzymes (2-fold above normal values)

• Hypercholesterolemia (fasting cholesterol > 8 mmol/l) or hypertriglyceridaemia (> 5 mmol/l) not controlled by lipid lowering therapy

• Granulocytopenia (white blood cell < 3,000/mm3) or thrombocytopenia (platelets < 100,000/mm3)

• Infection with hepatitis B or C, HIV

• History of malignancy

• Mental illness that interferes with the patient ability to comply with the protocol

• Drug or alcohol abuse within one year of baseline

• Co-medication with strong inhibitor of CYP3A4 and or P-gp like voriconazole, ketoconazole, diltiazem, verapamil, erythromycin or with a strong CYP3A4 and or P-gp inductor like rifampicin

• Known hypersensitivity to macrolides or Rapamune^®

• Patients who are unwilling or unable to give informed consent