价格60/千中文
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Safety: Safety assessments consisted of collecting all adverse events (AEs), serious adverse events
(SAEs), with their severity and relationship to study drug, and pregnancies. They included the regular
monitoring of hematology, blood chemistry and urine performed at (study center/central laboratory)
and regular assessments of vital signs, physical condition and body weight.
Pharmacodynamics: The PD assessment included determination of the effects of LCZ696 on 24 hr
sodium urinary excretion and determination of the plasma levels of atrial natriuretic peptide (ANP).
Statistical methods: The PK parameters of the three LCZ696 analytes: AHU377, LBQ657 and
valsartan, were summarized for each renal insufficiency category. The PK parameters of the matched
healthy subjects were summarized for each matched renal insufficiency category, and also as a
combined group. Analysis of variance (ANOVA) was performed for the log-transformed PK parameter
data (AUC0-24h, Cmax of Day 1 and 5) to compare the PK parameter of the renal impaired subjects in
each severity category with the age, gender, and BMI matched healthy volunteers.
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