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The more difficult video collection challenge in simulation is the information displayed by the clinical monitor (or patient monitor, or vital-signs monitor).
A clinical monitor of the sponsor in accordance with ISO 14155:2011 monitored this study.
The trial was monitored by an independent external clinical monitor and was prospectively registered on ClinicalTrials.gov No. NCT00146731.
We thank the study clinical monitor (Dr Mark Mukassa) and the data safety monitoring committee member (Drs Bernhards Ogutu, Fousseni Dao and Femina Mberesero), for their constant support.
The authors wish to gratefully acknowledge the valued contribution made by Dr Owen Harris who agreed to be the clinical monitor for this trial.
We also thank the DSMB members (Pr M. Soumaré, Dr B Kodio, Dr K Bojang, and Dr D. Diallo), the clinical monitor (Ms C. Bevilacqua) and the local safety monitor (Dr J-L Ndiaye) who provided invaluable comments and guidance.
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Clinical monitoring for reactions was performed during monthly clinic visits.
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