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Treatment safety was assessed histopathologically at 24, 48 and 264 h after inoculation.
Considering the clinical use of human MSCs, it is important to fully characterize these cells to assure treatment safety and efficacy.
They suggested some improvements surrounding bathroom facilities, mould treatment, safety issues at staff accommodation and providing information to staff about the "health impacts, if any, as a result of being geographically located near phosphate mining activity".
rhEGF plasma levels were almost undetectable, suggesting that no systemic absorption occurred, which may minimise potential side effects and improve treatment safety.
Treatment safety profile is hard to study too, primarily due to the sporadic report of AEs.
The term biomarker usually refers to any biological measurement that provides information regarding disease progression, relationship with treatment, safety and can be used for decision making in clinical or experimental applications.
Altogether 341 randomized subjects received at least one dose of the study treatment (safety population).
Secondary objectives included the duration of response (DOR), progression-free survival (PFS), OS, and treatment safety.
Primary end-points were treatment safety profile and efficacy according to the EULAR response criteria.
During the first stage, treatment safety was evaluated by interim analysis (n = 5).
Treatment safety data concur with the findings of previous studies [ 26- 29].
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