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All blood safety parameters remained within acceptable ranges.
Blood efficacy parameters were analysed in two central laboratories, blood safety parameters in local units.
No group differences in adverse event rates were found and no clinically relevant differences in blood safety parameters were noted.
Physical examination and blood safety parameters were part of the extensive safety analysis of PS that was performed.
All studies reported on HbA1c, fasting plasma glucose (FPG), weight, blood pressure and safety parameters (including urinary or genital tract infections and hypoglycaemia).
The rest failed to send in the diaries, did not leave blood for monitoring of safety parameters or did not take the study drug.
They returned to hospital 48, 96, and 144 or 168 h (6 or 7 days) after treatment for weight, supine BP, and heart rate measurements and for a blood sample to measure safety parameters and pharmacokinetics.
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Ha Thuy Vy
MA of Applied Linguistic, Maquarie University, Australia