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This thesis describes the development, implementation and preliminary results of the Arginine and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis (AVDAPT) randomised controlled trial. I had a central role in developing and implementing the study protocol collaboratively with my PhD supervisors Associate Professor Paul Kelly (Australian National University, Canberra) and Professor Nicholas Anstey (Menzies School of Health Research, Darwin), and with additional input from the investigators listed in Appendix 1. I wrote the initial draft of the study protocol for submission to the relevant ethics committees and for trial registration purposes (http://clinicaltrials.gov/show/ NCT00677339). I supervised and participated in the collection of. | Pulmonary Tuberculosis towards improved adjunctive therapies Anna Ralph July 2010 A thesis submitted in fulfilment of the requirements for the degree of Doctor of Philosophy of The Australian National University Front section Author s statement Author s statement This thesis describes the development implementation and preliminary results of the Arginine and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis AVDAPT randomised controlled trial. I had a central role in developing and implementing the study protocol collaboratively with my PhD supervisors Associate Professor Paul Kelly Australian National University Canberra and Professor Nicholas Anstey Menzies School of Health Research Darwin and with additional input from the investigators listed in Appendix 1. I wrote the initial draft of the study protocol for submission to the relevant ethics committees and for trial registration purposes http clinicaltrials.gov show NCT00677339 . I supervised and participated in the collection of data performed the data analyses wrote the thesis and wrote all published and submitted manuscripts arising from the thesis. The named co-authors made intellectual and writing contributions to the final manuscripts. One section of data analysis was not performed by me the interim safety analysis described in Chapter 10 was conducted by an independent biostatistician Mr Joseph McDonnell Menzies School of Health Research in his role as a member of the AVDAPT study Data and Safety Monitoring Committee. I am a named Chief Investigator on the successful National Health and Medical Research Council Project Grant Application 605806 entitled L-Arginine and Vitamin D Adjunctive Therapies in Pulmonary Tuberculosis . Anna Ralph BMedSci MBBS Hons MPH DTM H FRACP July 2010
