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Study design and settings: Forty-three patients have been enrolled in a multi-institutional prospective open enrollment study using the "Repose" bone screw system.
Prospective, observational, multicenter and voluntary enrollment study (Spanish registry ENVIN-HELICS) [1].
Because NVSA© diary completion started at enrollment (study week 0), week 1 NVSA© data (enrollment to week 1) were used for this analysis while KDQOL-36™ reflects enrollment (week 0) cPresence: FLIE Total < 108; Absence: FLIE Total ≥ 108.
Because NVSA© diary completion started at enrollment (study week 0), week 1 NVSA© data (enrollment to week 1) were used for this analysis while FLIE reflects enrollment (week 0).
At enrollment study subjects had a physical examination and medical history taken by the study nurse.
CM contributed to study enrollment, study logistics, quality control, and methods.
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In this table, among the 713 patients who were co-enrolled in another study, we present the co-enrollment study type (randomized trial, observational study), study genesis (investigator-initiated versus industry-initiated), affiliation with a research consortia, and the number of studies into which PROTECT patients were co-enrolled.
However, these studies have a number of limitations relating to the patient enrollment and study design.
Data on SOFA scores was collected on day 1 and day 2 of enrollment into study.
Sequential organ failure assessment (SOFA) score is presented for the day of enrollment in study.
See enrollment and study limitations for further detail.
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