Enrolled & Randomized (n=245 )

1. Did not meet eligibility criteria (n=57) • Other reasons: (n=14) • Time commitment (n=5) • Unable to contact (n=3) • Concern for risks (n=2) • Declined (n=1) • Accrual met/enrollment closed (n=2) • Unknown (n=1) Assessed for Eligibility (n=316) Enrolled & Randomized (n=245) 3·75 µg No adj. (n=28) 7·5 µg No adj. (n=29) 15 µg No adj. (n=27) 15 µg + AS03 (n=54) 3·75 µg + AS03 (n=53) 7·5 µg + AS03 (n=54) Dose 1 • Day 2 phone (n=53) • Day 8 visit (n=53) • Day 2 phone (n=54) • Day 8 visit (n=54) • Day 2 phone (n=27) • Day 8 visit (n=27) • Day 2 phone (n=29) • Day 8 visit (n=29) • Day 2 phone (n=28) • Day 8 visit (n=28) • Day 2 phone (n=54) • Day 8 visit (n=54) Dose 2 ineligible (n=1), abnormal clinical lab Dose 2 out-of-window (n=1) • Dose 2 ineligible (n=2) • Abnormal clinical lab • Illness, dermatitis after dose 1 • Dose 2 out-of-window (n=1) Dose 2 ineligible (n=5), all for abnormal clinical labs Dose 2 out-of-window (n=4) • Dose 2 ineligible (n=2) • HCV infection • Abnormal clinical lab • Dose 2 out-of-window (n=1) • Dose 2 ineligible (n=6) • abnormal clinical labs (n=3) • Ineligible at enrollment (n=2) • new medication (n=1) • Dose 2 out-of-window (n=2) Dose 2 ineligible (n=2), both for abnormal clinical labs Dose 2 refused (n=2) Dose 2 out-of-window (n=1) Per Protocol 3·75 µg + AS03 (n=44) 3·75 µg No adj. (n=25) 15 µg + AS03 (n=46) 7·5 µg No adj. (n=27) 15 µg No adj. (n=24) Dose 2 (Day 21) 7·5 µg + AS03 (n=49) • Day 21 blood (n=27) • Day 23 phone (n=24) • Day 29 visit (n=27) • Day 42 visit (n=27) • Day 81 visit (n=27) • Day 141 phone (n=27) • Day 201 visit (n=27) • Day 386 visit (n=26) • Day 21 blood (n=27) • Day 23 phone (n=25) • Day 29 visit (n=28) • Day 42 visit (n=28) • Day 81 visit (n=28) • Day 141 phone (n=28) • Day 201 visit (n=28) • Day 386 visit (n=28) • Day 21 blood (n=29) • Day 23 phone (n=26) • Day 29 visit (n=28) • Day 42 visit (n=28) • Day 81 visit (n=28) • Day 141 phone (n=28) • Day 201 visit (n=28) • Day 386 visit (n=27) • Day 21 blood (n=54) • Day 23 phone (n=45) • Day 29 visit (n=53) • Day 42 visit (n=51) • Day 81 visit (n=51) • Day 141 phone (n=51) • Day 201 visit (n=51) • Day 386 visit (n=50) • Day 21 blood (n=53) • Day 23 phone (n=43) • Day 29 visit (n=51) • Day 42 visit (n=51) • Day 81 visit (n=52) • Day 141 phone (n=50) • Day 201 visit (n=48) • Day 386 visit (n=47) • Day 21 blood (n=53) • Day 23 phone (n=49) • Day 29 visit (n=52) • Day 42 visit (n=51) • Day 81 visit (n=51) • Day 141 phone (n=50) • Day 201 visit (n=48) • Day 386 visit (n=47)