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It is therefore not possible to comment on the safety of doses >30 mg/kg per d in patients with low levels of iron loading.
The safety of doses >30 mg/kg per d was not assessed in patients with serum ferritin levels ≤1000 μg/l as only one patient had such low levels at dose escalation.
A larger study, involving 182 OLT patients, compared the efficacy and safety of doses of 60 μg/kg and 120 μg/kg rFVIIa 10 min before skin incision, followed by repeat dosing every 2 hours until 30 min before the expected start of reperfusion of the transplanted liver [ 14].
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This study will assess efficacy and safety of dose-intensified radiosurgery for painful vertebral metastases.
Additional clinical studies are required to analyze the safety profile of doses, route of administration, organ specificity, and bioavailability of these bioactive components in human subjects.
But the authors of the current study note that although dietary doses may be ineffective at prolonging life, the safety of higher doses is far from established.
This suggests that high doses may not be appropriate to predict the safety of low doses when hormonally active or modulating compounds are studied.
31 34 These studies, however, were not designed to directly assess the safety of different doses of MTX in combination with a fixed dose of adalimumab as was CONCERTO.
Most recently, the CURRENT-OASIS 7 trial evaluated the efficacy and safety of high-dose versus standard-dose clopidogrel in patients with ACS [ 20].
Other darbepoetin alfa investigations examining EDS dosing have reported thromboembolic rates similar to that observed in QW dosing, supporting the safety of this dosing regimen in CIA [ 10- 12].
The objective of the study was to assess the safety of large doses of rhGH therapy in human adults.
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