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Funding acknowledgement This project was funded by the NIHR Health Technology Assessment Programme (10/31/02) and is published in full in Health Technology Assessment.. Further information available at: http://www.nets.nihr.ac.uk/projects/hta/103102 This paper presents independent research commissioned by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, MRC, CCF, NETSCC, the HTA programme or the Department of Health. NIHR were not involved in the study design, collection, analysis and interpretation of data or in the writing of the articles for publication.