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After recruitment, GRS was re-calculated for each enrolled study participant based on repeat genotyping at a CLIA-certified laboratory.
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The study lasted from 30 June 2008 to 5 October 2010 and for each enrolled subject consisted of a screening period (3 8 weeks) and a treatment period (52 weeks).
It is noteworthy that there were no surgical complications for any enrolled study member.
The outpatient medical records for all enrolled study patients are stored in the University of Alberta Division of Gastroenterology electronic medical database (Wolf Medical system), where all clinic visits are recorded, including letters to and from referring primary-care physicians.
A simple case report form (CRF) was completed for each enrolled patient by study clinicians to obtain data regarding symptoms, disease duration, and treatment regimens as per the standard care at the study hospitals.
Study subject occupation was recorded, however students and children accounted for 63.5% of enrolled study subjects.
Sample sizes are presented for each study and for each relevant time category; the percentage of enrolled study members is then provided for each of the biologic or environmental samples.
The Principal Investigator or delegate will maintain source documentation for every participant enrolled in the study and all study forms for each enrolled participant will be stored securely in locked cabinets and will only be accessed by appropriately trained research staff.
Although ORs for GTG haplotype and SE alleles were higher in this study with adjustment for smoking than in a previous study without such adjustment [ 8], the enrolled study population was suitable for analyzing the effects of RA-risk PADI4 haplotype, SE alleles, and smoking in stratification with anti-CCP positivity and for assessing their interactions.
The enrolled study subjects were investigated for biochemical parameters like FBS, PPBS, HbA1c, FI, HOMA-IR and 25OHD levels in blood.
All data regarding clinical and imaging studies were obtained within two days after inclusion for each enrolled patient.
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