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VAEs were recorded as per modified CDC criteria (absence of quantitative microbiological testing) and compared against a surrogate marker of clinically diagnosed VAEs based on information available to the clinician.
A minimum target sample size of 2000 adults aged 25 to 64 stratified by sex and 10-year age group as per modified WHO STEPS[ 11] surveillance and Program for Detection and Management of Chronic Kidney Disease, Hypertension, Diabetes and Cardiovascular Disease in Developing Countries (KHDC)[ 12] questionnaires was used.
The concrete mix is designed for target strength of 40 MPa as per "Modified Nan-su Method", with Fly Ash as mineral admixture.
Asymptomatic patients with a positive biopsy as per Modified Marsh Score of 2 or greater with central pathology confirmation will be considered positive for CD, participants will be eligible for randomisation and participation in the intervention phase (figure 1 and box 1).
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Tumor response was assessed by investigators per modified RECIST v1.0 [ 12].
GDM was diagnosed as per the definition of WHO criteria as fasting PG (FPG) ≥7.0 or 2-h PG ≥7.8 mmol/l; and as per the modified IADPSG criteria as FPG ≥5.1 or 2-h PG ≥8.5 mmol/l.
Salinity was adjusted by adding dechlorinated municipal supply water or hypersaline (60‰) sea water (Instant Ocean, USA), as per methods modified from Kumlu et al. (2000, 2001), while water temperature was adjusted by applying either heated or chilled water to water baths until target temperatures were reached.
Odds ratio (OR) was calculated as per Haldane modified Woolf's formula [ 27].
Retinopathy status was scored clinically as per a modified Early Treatment Diabetic Retinopathy Study ETDRSseverityity scale.
The end products of LDL peroxidation, TBARS, were measured as per the modified method of Buege and Aust [ 48].
The agar well diffusion method was employed to determine antibacterial activity of extracts as per the modified method of Natarajan et al. [ 19].
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