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While these studies may show that high doses (e.g., a 700 mg intravenous infusion of a monoclonal antibody) are safe and well tolerated, study outcomes may lack biomarker or clinical signs due to the healthy volunteer population studied.
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The primary composite endpoint, success of prophylaxis, incorporated ability to tolerate study drug for ≥100 d (with ≤14 d interruption) with survival to day 180 without proven/probable IFI.
Because both agents have the potential to prevent IFI, including Aspergillus infections, the ability to tolerate study drug for relatively long durations becomes an important consideration.
The primary endpoint, success of prophylaxis, was defined as the ability to tolerate study drug for at least 100 d, with ≤14 d interruption, with survival without proven/probable IFI to day 180.
The gD2-AS04 vaccine was well tolerated by study participants for the duration of the study period.
In terms of reactogenicity, the gD2-AS04 HSvaccinene was well tolerated by study participants for the duration of the study period.
There were no adverse events reported during either study and the treatment was reported to be well tolerated by study participants.
There were no serious adverse events reported during the study and the treatment was reported to be well tolerated by study participants.
All subjects tolerated the study well.
In general, the treatment was reported to be extremely well tolerated by study participants.
The subjects tolerated the study medication and experimental procedures, and no adverse events were noted.
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