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Baseline safety and toxicity evaluations included history and physical examination, 12-lead ECG, and complete blood count with differential, metabolic, hepatic, and renal function assessments.
Children were evaluated at baseline and at seven subsequent annual intervals after initial dental treatments with an extensive battery of neurobehavioral, neurologic, and renal function assessments.
Our higher incidence of 18% can be attributed to our inclusion of cardiogenic shock or critical illness and our selected population in whom subsequent renal function assessments were necessary.
Renal function assessments consisted of estimated GFR (eGFR) as determined by the Modification of Diet in Renal Disease formula and estimated Cr clearance as determined by the Cockcroft-Gault formula.
Renal function assessments -urine output measurement, 24-hour urinary creatinine clearance A sample size calculation including a power calculation is not required as this study is a non-interventional study and is not intended to compare between different treatments or interventions.
Additionally, analysis of GFR data was performed on the per-protocol analysis set (PPAS) - defined as a subset of patients in the FAS, who completed the treatment period and who had no major protocol deviations that may impact renal function assessments.
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Renal function assessment and deterioration were assessed using international definitions.
Even when gadolinium cannot be administered because of impaired renal function, assessment of the vessel can be done with MRA techniques.
Serum creatinine was used for renal function assessment.
A close follow-up with haematologic profile and renal function assessment appears advisable in this subgroup of patients.
If the risk of nephrotoxicity is low, metformin can be re-instituted without the need for renal function assessment.
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