Author Contributions: Ms Daniels had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The authors listed in the byline constitute the Trial Management Group who managed the day to day conduct of the trial.
Study concept and design: Daniels, Gray, Gupta, Lilford, Khan.
Acquisition of data: Daniels, Gray, Latthe, Gupta, Selman, Adey, Xiong, Champaneria, Khan.
Analysis and interpretation of data: Daniels, Gray, Hills, Buckley, Gupta, Lilford, Khan.
Drafting of the manuscript: Daniels, Gray, Buckley, Adey, Champaneria, Khan.
Critical revision of the manuscript for important intellectual content: Daniels, Gray, Hills, Latthe, Gupta, Selman, Xiong, Lilford, Khan.
Statistical analysis: Daniels, Gray, Hills, Buckley, Champaneria, Khan.
Obtained funding: Daniels, Gray, Gupta, Lilford, Khan.
Administrative, technical, or material support: Daniels, Gray, Latthe, Gupta, Selman, Adey, Xiong, Khan.
Study supervision: Daniels, Gray, Gupta, Lilford, Khan.
Financial Disclosures: None reported.
Funding/Support: The work was funded by the Wellbeing for Women charity grant CT371 and Birmingham Women's Foundation NHS Trust Research and Development Committee, with additional support from the Birmingham Clinical Trials Unit, who are funded by the UK Department of Health. The LUNA trial was endorsed by the British Society of Gynaecological Endoscopy.
Role of Sponsor: The sponsor, under the UK Research Governance Framework, was the University of Birmingham. Neither the funding sources nor the sponsor played a role in the design and conduct of the study; collection, management, analysis, nor the interpretation of the data; and preparation, review, or approval of the manuscript.
LUNA Trial Coordination: Pallavi Latthe, MD, Tara Selman, PhD (clinical coordinators); Jane Daniels, MSc, Elizabeth Adey, BSc (trial managers); Robert Hills, PhD, Louise Hiller, PhD, Laura Buckley, PhD (statisticians); Tengbin Xiong, PhD, Rita Champaneria, MPhil (research associates); Rebecca Gair, MSc, Rebecca Powell, BSc, Leanne Lynch (trial administrators); Steve Goodsell, MPhil, Nick Hilken, PGDip, Edward Tyler, MSc, Adrian Wilcockson, BSc (database programmers). All trial administrators and database programmers were at the Birmingham Clinical Trials Unit, University of Birmingham, England, at the time the research was conducted.
LUNA Trial Collaborators: Khalid S. Khan, MD, MSc, Pallavi Latthe, MD, Tara Selman, PhD, Janesh K. Gupta, MD, MSc, Christopher Mann, MD, T. Justin Clark, MD, John Newton, MD (Birmingham Women's Hospital, Birmingham, England; n = 241 patients); Patrick Chien, MBChB, Maureen Macleod, BSc, RGN (Ninewells Hospital, Dundee, Scotland; n = 47 patients); James Thornton, MD, Elizabeth Rose, RGN (Nottingham City Hospital, Nottingham City, England; n = 40 patients); Mary Connor, MD, Andrew Baxter, MBChB, Tom Farrell, MD, Carmel Bonner, RGN (Royal Hallamshire Hospital, Sheffield, England; n = 39 patients); Vanessa Kay, MD, Wendy Crystal, RGN, Maureen Pheely, RGN (Forth Park Hospital, Kirkcaldy, Scotland; n = 34 patients); Shrin Irani, MD (Birmingham Heartlands Hospital, Birmingham, England; n = 22 patients); Linga Dwarakanath, MBBS (City Hospital, Birmingham, England; n = 14 patients); James Hollingworth, MD, Honest Honest, MD (Queen's Hospital, Burton-upon-Trent, England; n = 9 patients); Kirk Chin, MBBS (Staffordshire General Hospital, England; n = 8 patients); Joe Kabukoba, MD (Sandwell Hospital, West Bromwich, England; n = 8 patients); Jagbir S. Samra, MD, Charles W. Cox, MBBS (New Cross Hospital, Wolverhampton, England; n = 6 patients); Guy R. Fender, MD (Taunton and Somerset Hospital, England; n = 6 patients); Khaled M. K. Ismail, PhD (City General Hospital, Stoke, England; n = 3 patients); Stephen Keay, MBChB (Walsgrave Hospital, Coventry, England; n = 3 patients); Gabriel Awadzi, MBBS (Derriford Hospital, Plymouth, England; n = 2 patients); Edward J. Shaxted, MBBS, Rebecca Hitchcock, RN, Jill Smith, RGN (Northampton General Hospital, Northampton, England; n = 2 patients); Muhannad Zakaria, MBChB, Nita Beecham, RN (Yeovil District Hospital, Yeovil, England; n = 2 patients); William D. P. Phillips, MBChB (Perth Royal Infirmary, Perth, Scotland; n = 1 patient). Recruiting clinicians did not receive any financial incentive to take part in the LUNA trial.
Data and Safety Monitoring Board: Peter Brocklehurst, MSc, FRCOG (chair, University of Oxford), Joe Jordan, MD, FRCOG (retired), Peter Braunholtz, PhD (University of Aberdeen), Josie Sandercock, PhD (University of Birmingham).
Additional Contributions: We thank all of the women who participated in the trial for volunteering their help to improve the treatment of chronic pelvic pain.