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For the simulation, an input function obtained in the present clinical study was defined as true.
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Another issue that confounds interpretation of available data from clinical studies is defining endocrine status.
Success in our study was defined as both clinical and radiological improvement, with radiological improvement being documented as the complete or near complete resolution of the effusion on CT imaging obtained after fibrinolytic therapy.
The clinical health states for this study were defined as follows.
The main SLE clinical manifestations evaluated in this study were defined according to the American Rheumatism Association glossary committee [ 27].
A proof-of-concept (PoC) study is defined as a clinical trial carried out to determine if a treatment (drug) is biologically active or inactive [ 14].
Clinical prediction studies were defined as having content that pertains directly to the prediction of some aspect of a disease or condition, and the following methodologic criteria were applied: 1) the guide is generated in one or more sets of real patients (training set); and 2) the guide is validated in another set of real patients (test set).
Class III studies were defined as clinical series without concurrent controls, or studies with appropriate single-subject methodology.
A typical Phase III clinical study is well defined to maximize chances of a reliable outcome, generally involving clear inclusion criteria (with limited co-morbidities and concomitant medications), central review of key disease parameters, and strict management protocols.
Class II studies were defined as prospective cohort studies, retrospective case-control studies, or clinical series with well-designed controls.
However, future clinical study is needed to define our proposal.
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CEO of Professional Science Editing for Scientists @ prosciediting.com