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The initial cohort included 14,541 pregnancies and additional children eligible using the original enrolment definition (i.e. based on the same delivery dates) were recruited up to the age of 18 years, increasing the total number of pregnancies to 15,247.
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If positive they were classified as a treatment failure and re-treated with the original treatment given at enrolment.
All survivors were 5 or more years from their original diagnosis upon study enrolment.
Control subjects that developed IC after enrolment were re-enrolled as cases, and new controls were enrolled for the original case.
Informed consent was obtained from each patient prior to enrolment in the original "Outcome review of very low birth weight infants in Johannesburg" study.
At a median of 21.1 years after the time of enrolment in the original study, 366 of 372 patients (98.4%) were identified; of these, 81 (22.1%) had died.
Information on smoking in pregnancy was obtained during pregnancy at the time of enrolment in the original cohort, whereas those that participated only in the follow up answered retrospectively for the entire pregnancy.
All women and infants enrolled in the original cluster randomised trial (ACTNR 12610000944033) were eligible for enrolment in the study.
All women and infants enrolled in the original cluster randomised trial (ACTNR 12610000944033) were eligible for enrolment in the study if length-for-age z scores were available at 6 months of age.
Seventy six of the enrolled practices were from the original group of 160 practices targeted for enrolment, and the remaining 45 were from the open enrollment period.
The original 1964 version stated that the enrolment of patients in clinical trials must be justified by its therapeutic value for the patient, and revisions in 1975 added the requirement that the risks to participants should be minimised.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com