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CML, TM, and PR collected the data and developed the blinded database.
Those patients discharged with diagnoses indicative of potential ehrlichial infection, according to the International Classification of Diseases, 9th Edition (ICD-9), were identified by means of a blinded database review.
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All subjects, the investigator and the whole study staff involved in study performance and data analysis were blinded until database lock and deblinding.
who was blinded to the database classification of the subject.
All analyses were performed with a database blinded to treatment allocation.
Data analysts were not blinded after the database was locked for final analysis.
This was accomplished by this reviewer being blinded to the database and just reviewing death certificates and patient charts.
The cutoff between HRG-high and HGR-low subgroups was prospectively defined as the median measured on blinded samples before database lock.
The diagnostic information in the VCR was interpreted and transferred to the database blinded to the diagnostic information in the CCR.
All the subjects, Investigators, CRO and Sponsor staff involved in the study were blinded until the final database was locked.
FG will collect data out of the case record forms and will put them into a database (not blinded).
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CEO of Professional Science Editing for Scientists @ prosciediting.com