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Two licensed naturopathic doctors conducted enrollment and provided on site delivery of care (OS, KC).
The Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE), a prospective study of a subset of patients in the randomized controlled clinical ACCORD trial, is being conducted at enrollment and after 4 years of follow-up to assess the progression of DR with standardized comprehensive eye exams and fundus photography of 7 standard stereoscopic fields.
Study interventionists conducted the enrollment visits.
Assessments will be conducted at enrollment, and at 6-weeks, 6-months, and 12-months postpartum by trained bicultural and bilingual personnel blinded to the intervention arm.
At least one interim home visit was conducted between enrollment and the start of the intervention when the infant reached 6 months.
An interim safety review was conducted after enrollment of the first 30 patients (20 randomized to lapatinib plus vinorelbine, 10 randomized to lapatinib plus capecitabine) [ 16].
Usually within three weeks (but always prior to the next oncology visit), a study representative conducted an Enrollment Interview by phone.
Chart reviews are conducted at enrollment and at the conclusion of the study or at the time of the child's death.
We evaluated knowledge on a survey conducted at enrollment in the cohort at ≤ 20 weeks gestation and evaluated participant satisfaction with the KT tool in the third trimester.
While data for CD4 tests conducted after enrollment was available, CD4 count data was not available for all patients at regular intervals therefore we did not examine CD4 as a time-dependent covariate.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com