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Other measures of glycaemia and hypoglycaemia, weight change and insulin dose were assessed.
Biological parameters such as Hb, calcium, phosphorus, urea, creatinine and DA dose, were assessed every other week; iron dose was recorded every week.
Daily doses of 60 mg and 90 mg (1.5 times the maximum recommended daily dose) were assessed in patients with chronic low back pain; daily doses of 90 mg and 120 mg (1.33 times the maximum recommended daily dose) were assessed in patients with ankylosing spondylitis.
The incidences of adverse events (AEs) with grade 3 intensity (primary objective) or of any intensity (secondary objective), and the immunogenicity (secondary objective) of the PHiD-CV booster dose were assessed.
Justification of examination (matching clinical indications and imaging findings), optimisation of scanning parameters such as mAs and KVp as well as radiation doses in dose length product (DLP) and effective dose were assessed.
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Further, suppression of the hypothalamic pituitary adrenal axis (HPAA) at each dose was assessed.
Human radiation dose was assessed using OLINDA software.
Exposure interface dose was assessed in two ways: gravimetric mass of deposited particles with QCMs and quantification of nicotine from the exposed QCM surface.
Plasma volume expansion as a percentage of the administered dose was assessed to test the hypothesis that efficacy of crystalloids as plasma volume expanders differs between the two inflammatory conditions.
Each dose was assessed in four patients.
Each dose was assessed in four patients over 2 days.
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