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Second French Trial Tragedy Verdict: No Danger Signs In Lower Dose Triallists

Executive Summary

A second committee has given its opinion on the Phase I trial tragedy in France earlier this year in which one volunteer died and four others were hospitalized after suffering neurological damage. The panel found that while some neurological signals were seen in about half of the other 80-odd volunteers, these were in line with what would be expected in a first-in-human clinical trial and differed from the lesions seen in the volunteers who were hospitalized.

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