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Title
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Results at 30 months of a randomised trial of FDCs and separate drugs for the treatment of tuberculosis
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Author
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Abstract
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| Study C was an open-label, non-inferiority, randomised controlled trial of fixed-dose combination (FDC) or separate drugs given during the intensive phase of treatment to 1585 patients with smear-positive pulmonary tuberculosis conducted at 11 sites in Africa, Asia and Latin America. Thirty months post-randomisation, the failure/relapse rates in the per protocol population were 7.4% of 591 patients on FDCs and 6.5% of 587 patients on separate drugs; the site-adjusted difference was 0.3% (90%CI −1.8 to 2.3). In the modified intention-to-treat analysis, the corresponding results were respectively 17.9% of 683 and 16.1% of 671; the site-adjusted difference was 2.0% (90%CI −1.2 to 5.2). |
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Language
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English
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Source (journal)
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International journal of tuberculosis and lung disease. - Paris
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Publication
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Paris
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2014
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ISSN
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1027-3719
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DOI
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10.5588/IJTLD.14.0281
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Volume/pages
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18
:10
(2014)
, p. 1252-1254
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ISI
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000342270000020
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Full text (Publisher's DOI)
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