Informed written consent will be obtained before study commencement and data collection.
Analysis of EPA in patients' plasma phospholipids before study commencement and at 8 weeks was performed by gas chromatography as described previously (Wigmore et al, 1996).
Blood and urine samples for clinical laboratory tests, including hematology, serum chemistry, and urinalysis, were collected at screening on the day before study commencement and on the second day of each treatment period, as well as at discharge or early termination from the study.
Participants and their families were contacted by telephone 2 weeks before study commencement to review BGLs and adjust insulin therapy to optimize waking BGLs (4 8 mmol/l) and minimize the risk of hypoglycemia, defined as symptomatic or BGL <3.5 mmol/l.
Two participants withdrew before study commencement for personal reasons, and one participant was excluded because of an inappropriate A1C.
Delegated study staff will receive formal training in measurement techniques of arterial stiffness and undertake a reproducibility and measurement quality study before study commencement.
For each participating resident, data collected included gender, age on admission, date of admission, from where the resident was admitted, presence of an indwelling urinary catheter, systemic antimicrobial treatment, and hospitalisation in the previous 12 months, and previous ESBL, CPE, VRE, and MRSA result recorded before study commencement.
Before study commencement, orange juice (supplied by the Florida Department of Citrus) and hesperidin supplement (a kind gift from Miguel Aragüés, Alicante, Spain) were analyzed for hesperidin, narirutin, and vitamin C content by using HPLC-diode array detection (14) (typical chromatograms are shown in Supplemental Figure 1).
A data safety monitoring board consisting of two independent clinicians and one independent statistician was established before study commencement to regularly review de-blinded data.
An institutional review board for each site (listed in the Appendix) approved the protocol, and all patients provided written informed consent before study commencement.
