Word count: 2462
Conflict of Interest: nil
Acknowledgements:
S.Takuva performed the initial search on the Sisonke database. C Day and J.Peter analysed the data, contacted patients, adjudicated all cases, and wrote the original draft of the manuscript. J.Peter, S. Takuva, A.Takalani, I. Engelbrecht, N. Garrett, A. Goga, V. Louw, J. Opie, B. Jacobson, I. Sanne, L. Gail-Bekker, and G. Gray are on the Sisonke safety committee. G. Gray is the primary investigator in the Sisonke study. All authors were involved in editing the manuscript. The Sinsonke Study is funded by the South African Medical Research Counsel. J. Peter’s research is supported by a career development award (K43TW011178-04) and receives financial support from National Institutes of Health, award K43TW011178-02; the European Developing Clinical Trials Partnership (EDCTP2 Program supported by the European Union Grant Number TMA2017SF-1981 ) and the SA Medical Research Council and National Research Foundation (NRF).