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Posted On: 06/03/2021 8:06:57 AM
Post# of 72444
Was a bit surprised by the 60 day monitoring requirement in the PR but this is due to the following statement in the trial protocol:
Incidence of treatment-emergent adverse events [ Time Frame: Day 1 through Day 60 ]
Treatment-emergent Adverse Events (TEAEs) have onset dates on or after the study treatment start date
Incidence of treatment-emergent adverse events [ Time Frame: Day 1 through Day 60 ]
Treatment-emergent Adverse Events (TEAEs) have onset dates on or after the study treatment start date
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