Table 3b. Study Schedule – Multiple dosing regimen.

Activity	Screening (Day -28 to Day -2	Randomisation (Day -27 to -2)	Day -1	Day 0	Day 1	Day 2	Day 3	Day 5	Day 42	6-month telephone visit
In-patient stay
Informed consent
Inclusion/exclusion criteria
Demographic data (including smoking history)
Medical history
Viral serology
Pregnancy test a
Provide results to investigations
Randomization
Study residency:
Check in
Check out							b
Non-residential visit
Study drug administration f
Safety and tolerability: c
Adverse event recording d
Vital signs (including blood pressure and pulse rate)
Axillary body temperature
12 lead ECG e
Clinical laboratory evaluations (including haematology, clinical chemistry, and urinalysis)
Body weight (and height at first visit)
Physical examination
Concomitant medication
Blood sampling
Pharmacokinetics:
Pharmacodynamics:

ECG, electrocardiogram.

^a Females aged 18 to 64 years. Performed in urine.

^b In house stay until 24 hours post-dose.

^c The timings of all measurements to be performed during the study may be subject to change based on the ongoing review of the safety, tolerability, pharmacokinetic and pharmacodynamic results.

^d Serious adverse events will be recorded from enrolment, and adverse events will be recorded from dose administration until the final follow up Visit.

^e Resting 12 lead ECG: at Screening; and Day 1 post dose and prior to discharge from inpatient facility. Additional ECG recordings will be taken at the discretion of the responsible clinician.

^f Doses anticipated to be administered four times per day for up to 72 hours.