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The severity of the MRPs and the likely consequences if they had not been addressed will be assessed by an expert panel using a risk classification system [ 22].
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FDA uses a risk-based classification system based on the risk to the patient due to false results: class I with low risk is exempted; class II with medium risk requires 510(k) pre-market notification; class III with high risk requires Pre-Marketing Approval (PMA).
A year later, in a separate hearing, J. G. was assigned a risk classification.
3 Patients were stratified into four risk groups using a modified WHO risk classification for pregnant women with cardiac disease.
The potential risk classification for malignancy was evaluated using AFIP Miettinen risk classification criteria [ 6, 24].
No major differences were found by using alternative risk classification scales according to Miettinen et al., Hornick et al. and Joensuu [ 4, 6, 7].
Using traditional risk classifications, a large proportion of patients are classified as intermediate risk, which is uninformative for choosing optimal treatment strategies for the individual patients.
Use of the YASI results in a score that is used for risk classification (M. Lewis, personal communication, October 10 , 2012 and the scores help probation officers develop the case plans for youth.
A similar pattern was obtained when using the frequent/infrequent risk classification definition.
> -wrap-foot> confidencence interval, COPD chronic obstructive pulmonary disease, HR hazard ratio A similar pattern was obtained when using the frequent/infrequent risk classification definition.
Two authors (DC and JA) independently analysed the quality of reporting by using a qualitative classification according to risk of bias (high, unclear, or low).
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CEO of Professional Science Editing for Scientists @ prosciediting.com