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The primary outcome was a good neurological status at 6 months, defined by a modified Rankin score ≤2.
Skeletal maturity is reached at the age of 18 months, defined by closing of the distal femoral growth plates and the characteristics of mature cartilage (Hurtig et al. 2011).
Paralleling a previous analysis, long-term treatment with delamanid was indicated as ≥6 months, defined by assignment to delamanid or placebo in Trial 204 and participation in Trial 208, and short-term treatment with delamanid was indicated as ≤2 months, defined by assignment to delamanid or placebo in Trial 204 and no participation in Trial 208 [ 6].
Unfavourable outcome measured by DDS showed sensitivity of 73%9595% CI 69 to 76%) and specificity of 56% (53 to 59%) for prediction of unfavourable outcome at 12 months defined by GOS.
To assess the responsiveness of the Multiple Sclerosis International Quality of Life (MusiQoL) questionnaire to change in disability over 24 months, defined by change in the Expanded Disability Status Scale (EDSS) score.
Exclusive breastfeeding at 8 12 weeks was chosen as an outcome rather than the standard 6 months defined by the WHO because the study was not originally designed to capture breastfeeding outcomes.
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Death or severe disability at six months (defined as death by 6 months or before discharge from hospital at any time to end of data collection, or where the answer to the first two questions of the Euroqol questionnaire (EQ5D) are 'confined to bed' and 'unable to wash or dress yourself').
Fifty-six of the 67 (84%) patients had sustained treatment success at 24 months, defined as an improvement by at least one Stamey Score grade compared to baseline.
Nine patients (21%) developed cardiotoxicity (1 at 3 months and 8 at 6 months) as defined by the Cardiac Review and Evaluation Committee reviewing trastuzumab.
Linear regression analyses were performed to investigate the role of these four factors in predicting response to treatment by 6 months, defined as the absolute change in 28-joint Disease Activity Score (DAS28).
Men and women aged 18 70 years were eligible if they had had RA for ≥6 months as defined by the American College of Rheumatology criteria, 30 received methotrexate treatment for ≥3 months (stable dose of 10 25 mg/week for ≥8 weeks) and had a Disease Activity Score 28-joint assessment (DAS28) ≤4.8 (mild to moderate) for ≥3 months.
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