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dc.contributor.authorLim, C
dc.contributor.authorBaker, A
dc.contributor.authorSaha, S
dc.contributor.authorFoley, S
dc.contributor.authorGordon, A
dc.contributor.authorWard, D
dc.contributor.authorBurgher, B
dc.contributor.authorDark, F
dc.contributor.authorBeckmann, M
dc.contributor.authorStathis, S
dc.contributor.authorBruxner, G
dc.contributor.authorRyan, A
dc.contributor.authorRichardson, D
dc.contributor.authorHatherill, S
dc.contributor.authorBerk, M
dc.contributor.authorDean, O
dc.contributor.authorMcGrath, J
dc.contributor.authorChapman, J
dc.contributor.authorPatterson, S
dc.contributor.authorSingh, S
dc.contributor.authorMowry, B
dc.contributor.authorTracy, L
dc.contributor.authorDuhig, M
dc.contributor.authorMachin, A
dc.contributor.authorTroman, E
dc.contributor.authorSuetani, S
dc.contributor.authorDinala, T
dc.contributor.authorBurton, L
dc.contributor.authorCosgrove, P
dc.contributor.authorGamble, C
dc.contributor.authorScott, J
dc.date.accessioned2020-03-03T02:34:39Z
dc.date.available2020-03-03T02:34:39Z
dc.date.issued2019
dc.identifier.issn1745-6215
dc.identifier.doi10.1186/s13063-019-3232-8
dc.identifier.urihttp://hdl.handle.net/10072/392074
dc.description.abstractBackground: CADENCE-BZ is a multi-centre, parallel-group, double-blind randomized controlled trial designed to examine the clinical efficacy and safety of an accessible food preservative, sodium benzoate, as an add-on treatment for patients with early psychosis. The original study protocol was published in 2017. Here, we describe the updated protocol along with the Statistical Analysis Plan (SAP) for the CADENCE-BZ trial prior to study completion. Methods and materials: Two important changes were made to the original protocol: (1) improvements to our statistical analysis plan permitted a reduction in sample size; and (2) a revision in the secondary outcomes with the intent of reducing redundancy and excluding those measures that were not appropriate as outcomes. Conclusions: We provide the updated SAP prior to the completion of the study with the intent of increasing the transparency of the data analyses for CADENCE-BZ. The final participants are currently completing the study and the results will be published in the near future. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12615000187549). Registered on 26th February 2015.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherBioMed Central
dc.publisher.placeUnited Kingdom
dc.relation.ispartofpagefrom203: 1
dc.relation.ispartofpageto203: 4
dc.relation.ispartofissue1
dc.relation.ispartofjournalTrials
dc.relation.ispartofvolume20
dc.subject.fieldofresearchClinical Sciences
dc.subject.fieldofresearchCardiorespiratory Medicine and Haematology
dc.subject.fieldofresearchcode1103
dc.subject.fieldofresearchcode1102
dc.subject.keywordsEarly psychosis
dc.subject.keywordsPANSS
dc.subject.keywordsRCT
dc.subject.keywordsRandomized clinical trial
dc.subject.keywordsSodium benzoate
dc.titleProtocol update and statistical analysis plan for CADENCE-BZ: A randomized clinical trial to assess the efficacy of sodium benzoate as an adjunctive treatment in early psychosis
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationLim, C; Baker, A; Saha, S; Foley, S; Gordon, A; Ward, D; Burgher, B; Dark, F; Beckmann, M; Stathis, S; Bruxner, G; Ryan, A; Richardson, D; Hatherill, S; Berk, M; Dean, O; McGrath, J; Chapman, J; Patterson, S; Singh, S; Mowry, B; Tracy, L; Duhig, M; Machin, A; Troman, E; Suetani, S; Dinala, T; Burton, L; Cosgrove, P; Gamble, C; Scott, J, Protocol update and statistical analysis plan for CADENCE-BZ: A randomized clinical trial to assess the efficacy of sodium benzoate as an adjunctive treatment in early psychosis, Trials, 2019, 20 (1), pp. 203: 1-203: 4
dcterms.dateAccepted2019-01-29
dcterms.licensehttp://creativecommons.org/licenses/by/4.0/
dc.date.updated2020-03-02T00:46:34Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© 2019 The Authors. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
gro.hasfulltextFull Text
gro.griffith.authorSuetani, Shuichi


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