Assessment/Procedure Screening (Days) Treatment Period (Weeks) Follow-up (Weeks)   -35 to -1 BL 1 2 4 8 12 18 24 32 40 48 52 60 72 Informed Consent X                             Complete Medical History, including family history of HBV X                             HBV histological confirmation X                             Physical examination X                             Ophthalmologic examination X Repeat in patients with preexisting findings or those developing symptoms Vital Signs&Symptom-Directed Physical X X X X X X X X X X X X X X X Urine or serum HCG Pregnancy X                             Chest x-ray (selected patients) X                             Ultrasound, CT or MRI (selected patients) X                             Electrocardiogram (selected patients) X                             Alfa-fetoprotein X                             Anti-HAV IgM, anti-HCV, anti-HIV, anti-HDV X                             alfa 1, AT, AMA, ANA, ASMA X                             Hematology X X X X X X X X X X X X X X   ALT only       X X X X X X X X X X X X Chemistry X X     X   X   X X   X X X X HBeAg, anti-HBe X X         opt   opt opt   X opt   X HBV DNA X X*         opt   opt opt   X     X HBsAg, anti-HBs X                     X     X Adverse Events (h) X X X X X X X X X X X X X X X Drug accountability/ compliance   X X X X X X X X X X X       Concomitant medication X X X X X X X X X X X X X X X *opt - optional

Table 2: Assessments schedule.