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XC, JG, YH, and CPW contributed to the principal aspects and supervised the progress of the research.
JHB performed the data analysis and supervised the progress of the paper.
LM has been the primus of this project and has guided and supervised the progress of both the project and the manuscript.
The data safety monitoring board (DSMB) was sponsored by WHO and monitored both adherence to the trial protocol and supervised the progress of the trial toward its objectives via interim analyses of selected outcome data by randomization groups.
PP had a major role designing the study, he also participated in patients recruitment, helped data analysis and supervised the progress of the study, in addition, he wrote the first draft of the manuscript and re edited it following all the other authors input.
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To monitor and supervise the progress of the TOBY study towards its interim and overall objectives.
Monitor and supervise the progress of the trial towards its interim and overall objectives.
The remit of the TSC is to: Monitor and supervise the progress of the trial towards its interim and overall objectives.
Independent trial and safety monitors were appointed to monitor and supervise the progress and safety of the trial throughout and ensure the study abided by MRC UK Good Clinical Practice standards.
It is the role of the DMC to monitor and supervise the progress of the trial (including safety data and adherence to the protocol) and to advise whether to continue, modify or stop the trial.
GM and GX supervised the progress of the study and revised the manuscript critically.
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