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isaphttp://webisa.webdatacommons.org/prov/
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provhttp://www.w3.org/ns/prov#
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Any serious event (including on-site and off-site adverse events, injuries, side effects, deaths or other problems) which in the opinion of the local investigator was unanticipated, involved risk to subjects or others, and was possibly related to the research procedures.
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n5:edu
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