Results of vital signs measurements, physical examination and safety laboratory tests were also analysed descriptively.
During the surgical period the following safety assessments were performed: adverse events (daily), vital signs, ECG, physical examination and safety laboratory parameters.
All patients underwent a complete history and physical examination, ECG, biological and CBC before entry, then weekly CBC and every 2 weeks, physical examination and safety evaluation of the treatment along with biochemistry.
The study investigators performed efficacy (clinical, radiological, and mycological examinations) and safety evaluations every 3 months, which helped to determine treatment duration.
β-Cell function was assessed using HOMA2-%B, HOMA2 calculator version 2.2 (Oxford, U.K ., with fasting glucose and C-peptide values at baseline and at week 12. Safety and tolerability assessments included collection of adverse event (AE) reports, vital signs, 12-lead electrocardiograms, physical examinations, and safety laboratory assessments.
The goals of the irradiation experiments are to provide irradiation performance data to support fuel process development, to qualify fuel for normal operating conditions, to support development and validation of fuel performance and fission product transport models and codes, and to provide irradiated fuel and materials for post irradiation examination (PIE) and safety testing.
Physical examination and blood safety parameters were part of the extensive safety analysis of PS that was performed.
Participants are assessed at baseline, 3, 6, 9, 12 and 24 months with clinical examination and blood safety tests.
The team will check patients at each visit for symptoms due to therapy; a physical examination and complete safety labs should be performed.
A clinical examination and laboratory safety tests were performed during screening and 6 days after artesunate administration and 20 days after administration of both amodiaquine and amodiaquine plus artesunate.
Patient histories, including performance status, concomitant medications, physical examination and laboratory safety variables, were measured at screening, at each treatment visit during each study and at follow-up by the responsible local laboratories at each centre.
