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CRFs were reviewed and collected by the study monitor.
We are indebted to Drs Shaf Ahmed, Frank Bell and Grace Malenga as the study Safety Management Committee and to Dr Neena Bodasing for acting as the study monitor.
Regular meetings will take place with the study monitor.
Team members, E.L., L.E., GG., and PL, met periodically to design the study, monitor implementation, and discuss results.
All cases of CAP were reported, via a network of sentinel practices and hospitals, to the study monitor of the corresponding local clinical center.
60 All SAEs occurring during the study will have a separate notification form and be reported by the principal investigator to the sponsor and the study monitor.
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The study monitored the subjects' skin temperatures, recorded their thermal sensations, and measured several outdoor environmental parameters.
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MC participated in the design of the study, monitored the field work and drafted the manuscript.
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