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A protocol amendment was introduced for Part B to exclude enrolment of patients with sodium <135 mmol l−1, and the incidence of hyponatraemia declined substantially (Table 3).
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Participants with follow-up <1 year (n=6188), or with prevalent cancer (other than non-melanoma skin cancer), were excluded before enrolment or within 1 year after enrolment (n=2149).
An additional 8 children were excluded post enrolment either because their guardians withdrew consent within less than 8 weeks from enrolment (n = 6) and/or because they had very poor and erratic attendance (n = 2).
Of these, 21 were excluded from enrolment due to chronic illness, permanent disability or because they were severely malnourished.
In the PP analysis, patients lost to follow-up and those excluded after enrolment were excluded from the analysis, and only patients with complete follow-up were included in the denominator.
One subject was excluded after enrolment due to language/communication problems.
One patient was excluded at enrolment as he was detected to have asymptomatic sick sinus syndrome.
133 were excluded before enrolment and 152 were excluded during the first and second visit at the spine clinic.
23 24 Patients undergoing elective revascularisation within 3 months after CTA or MPI (early elective revascularisation) were excluded after enrolment.
Since cases with BPD of known genetic aetiology were excluded from enrolment, we predicted that causal variants in the ThromboGenomics genes would be uncommon.
Women with a known multiple gestation pregnancy or who had a multiple birth were excluded at enrolment or during the study.
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CEO of Professional Science Editing for Scientists @ prosciediting.com