Other contributions: We thank coinvestigators Dr Virginia Reid (Newcastle), Dr Daniel Chambers (Royal Perth), Dr Geoffrey Eather, Dr Andreas Fiene, Dr Kevin Tan, Dr Sappani Sivakumar, Dr Mark Teh, and Dr Jeanie Leong (Sir Charles Gairdner); study coordinators Nicole Lachapelle, Karen Collins (Hollywood Private), Anne-Marie Morrison (Royal Perth), and Kerry Boughton (Sir Charles Gairdner); Kristie Black, Michelle Radcliffe, Jillian Freeman, Noelene Wilson, Paul Handsaker (Hunter Immunology Ltd R&D unit); and Ngan Pham and Frank Kosaras (Perth micro laboratory for microbiological assays). We also thank statisticians Professor Cate D’Este (University of Newcastle), Peter Mullins (Sage Consultants Ltd, Warkworth, NZ), Nicholas Pready, and Dr Jonathan Alsop (Kendle International Inc., UK), who all provided independent statistical review of the data. Professor D’Este is with the University of Newcastle, Australia. Mr Mullins, Mr Pready, and Dr Alsop are professional consultants. This work was performed at Hollywood Private Hospital, Perth, WA; Sir Charles Gairdner Hospital, Perth, WA; Royal Perth Hospital, Perth, WA; and the University of Newcastle, Newcastle, NSW.