The study will consist of 3 phases - the Baseline, In-hospital Phase and Follow up Phase. Baseline is from study entry through randomisation; the In-hospital phase is from treatment with study drug through hospital discharge or day 7, whichever occurs first. The follow up phase consists of visits to the hospital 30 days (+ 3 days) from the day of study drug administration. Hospital discharge is defined as the end of the discharge from the acute hospital setting. Discharge may be to home, to a rehabilitation setting or to a non-acute hospital setting.