About the Authors
- James A. McIntyre, Glenda E. Gray, Neil A. Martinson
- Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa
- Mark Hopley, Marie Eklund
- Boehringer Ingelheim, Johannesburg, South Africa
- Daya Moodley
- Department of Obstetrics and Gynaecology, Nelson Mandela School of Medicine, University of KwaZulu Natal, Durban, South Africa
- David B. Hall, Patrick Robinson, Douglas Mayers
- Boehringer Ingelheim Pharmaceuticals, Ridgefield, Connecticut, United States of America
- Neil A. Martinson
- Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America
M. Hopley, M. Ekelund, D. B. Hall, and P. Robinson are employed by Boehringer Ingelheim, the sponsor of the study, and D. Mayers was employed by Boehringer Ingelheim at the time of the study. Employees of the sponsor were involved in protocol design, were responsible for data management and statistical analyses, and assisted with the preparation of the paper. J. A. McIntyre and G. E. Gray have received research funding, travel grants and speaker's honoraria from Boehringer Ingelheim and Glaxo SmithKline. N. A. Martinson and D. Moodley declare no competing interests.
ICMJE criteria for authorship read and met: JMc MH DMo ME GEG DH PR DMa NAM. Agreed with manuscript s results and conclusions: JMc MH DMo ME GEG DH PR DMa NAM. Designed the experiments/the study: NAM DMo ME JMc PR DH DMa. Analyzed the data: NAM JMc MH DH DMa GEG. Collected data/did experiments for the study: JMc ME DH DMa GEG. Enrolled Patients: DMo ME GEG. Wrote the first draft of the paper: NAM MH JMc. Contributed to the writing of the paper: NAM JMc MH DMo PR ME DH DMa GEG. MH was responsible for the conduct of the trial and, with ME and DMa, oversaw data management. Analysis was undertaken by DH and DMa, directed by JMc, NAM, and MH with assistance from GEG. NAM and DMo assisted in recruitment of participants. NAM, MH, and JMc, wrote the paper with assistance from DH, DMa, ME, DMo, PR, and GEG. The sponsor has given an assurance that all authors have full access to the trial dataset.