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Abbott said yesterday that it was confident that Synthroid was safe and that it planned to file studies with the F.D.A. that proved so in the next few weeks.
Under Dutch law, retrospective file studies are exempted from review by an accredited ethics committee.
This incidence is greater than previously observed for ALT/AST elevations >3 × ULN with lumiracoxib 100 mg o.d. in long-term clinical trials (0.91%) (Novartis: data on file, Studies 2360 [core plus extension] and 2361 [core plus extension] pooled).
The safety and tolerability profile was also consistent with that observed at these doses in previous single and repeated dose studies of ADX10059 in healthy subjects (refs. Data on file, studies ADX10059-101, 102 and 103).
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Cross-sectional patient file study.
The three files are called Investigation file, Study file, and Assay file.
In a medical file study, we will investigate whether people have an advance directive in their medical file (and study its content).
Ethical approval was not necessary under Dutch regulations since this study was a retrospective patient file study.
The next step in this process is a limited patient file study to compare rehabilitation plans based on the regular intake and on the D-AI.
Another limitation of the study is the exclusion of Human-Computer Interaction (HCI) filed studies.
The QLQ-C30 has been tested in EORTC filed studies [ 24] and is nowadays a very well validated instrument.
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