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Physicians made dose adjustments for patients on the first and the last two days of the camp.
When made, dose adjustments occurred at weekly intervals and in increments/decrements of 40 mg/day, based on investigator judgment in order to optimize efficacy and tolerability.
It is quite conceivable that in addition to consideration of renal function, prescribers may have made dose adjustments on the basis of other parameters like the blood pressure, heart rate, electrolyte levels.
In both studies, investigators made dose increases or decreases as clinically indicated; while they were blinded with respect to the actual treatment, they were aware of the dose level as expressed by the number of capsules prescribed.
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Results demonstrated that C. copticum made dose-dependent relaxation (dose 0.1 1 mg/mL) with a possible mechanism of calcium channel blocking effect [ 25].
Recent advances in radiotherapy technology – intensity modulated radiotherapy for generation of highly conformal dose distributions and image-guidance for precise treatment delivery – have made dose-escalated radiosurgery of spinal metastases possible and early results of pain and local tumor control are promising.
"We considered making Dose more mission-driven," he said.
Included in making dose assessments for the three CoP are calibration coefficients for a range of beam quality indices.
The absence of an MTD, of course, makes dose selection for phase 2 studies challenging.
Physicians may have used guidelines other than the one we used in the study to make dose adjustments.
Furthermore, the dose response relationship may depart from linearity at low doses (Vandenberg et al. 2012), making dose extrapolation difficult and potentially unreliable.
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