Author's response to reviews

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1 Author's response to reviews Title:The SABATO trial study protocol: A randomized, parallel-group, observer-blinded clinical non-inferiority trial of early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection Authors: Achim J Kaasch (achim.kaasch@uk-koeln.de) Gerd Fätkenheuer (gerd.faetkenheuer@uk-koeln.de) Reinhild Prinz-Langenohl (reinhild.prinz-langenohl@zks-koeln.de) Ursula Paulus (ursula.paulus@uk-koeln.de) Martin Hellmich (martin.hellmich@uni-koeln.de) Verena Weiss (verena.weiss@uni-koeln.de) Norma Jung (norma.jung@uk-koeln.de) Siegbert Rieg (siegbert.rieg@uniklinik-freiburg.de) Winfried V Kern (winfried.kern@uniklinik-freiburg.de) Harald Seifert (harald.seifert@uni-koeln.de) Version:3Date:7 July 2015 Author's response to reviews: see over

2 Uniklinik Köln IMMIH Goldenfelsstr Köln Trials Editorial Office Priv.-Doz. Dr. Achim J. Kaasch Institut f. Medizinische Mikrobiologie, Immunologie und Hygiene Telefon: Telefax: July 7 th, 2015 Dear Sir or Madam Please find attached the resubmission of the manuscript. All suggested changes have been applied and listed below. Best Regards Achim Kaasch Kerpener Straße Köln Telefon: Telefax: Universitätsklinikum Köln (AöR) Vorstand: Prof. Dr. Edgar Schömig (Vorsitzender und Ärztlicher Direktor) Dipl.-Kfm. Günter Zwilling (Kaufmännischer Direktor) Prof. Dr. Joachim Klosterkötter (Dekan) Dipl. PM (FH) René Bostelaar (Pflegedirektor) Prof. Dr. Peer Eysel (stellv. Ärztlicher Direktor) Bank für Sozialwirtschaft Köln BLZ: Konto: IBAN: DE BIC: BFSWDE33XXX Steuernummer: 223/5911/1092 Ust-IdNr.: DE IK: ÖPNV: Straßenbahn Linie 9 Hst. Lindenburg, Linie 13 Hst. Gleueler Str./Gürtel Bus Linie 146 Hst. Leiblplatz

3 Comments to authors. Recommendations for improvement. 1. P(age) 2, l(ine) 19 Spell out [430] in words. 2. P 3, l 27. Include the date of registration as well as the date the first patient was randomized in December See P 14, l P 4, l 47. Suggest replacing [significant] by another word such as [much]. Save significant for statistically supported statements. REPLACED by much 4. P 6, l 91. Since [or] logically includes [and], delete [and/]. 5. P 6, l 96. Suggest inserting [center stratified] after [multicenter]. 6. P 9, l 182. Suggest adding a [)] after [appropriate]. 7. P 10, l 197. Suggest rewriting as [72 h]. Also P 22, left column, first dash, l 1. Also P 22, right column, third dash, l 2 and fourth dash l P 11, l 212. Delete [in order] in front of [to] as the words are redundant in English. Also is there a citation to justify double margin adequacy for a non-inferiority trial? Please add it. ADDED Ref 24: Bauer et al. Testing strategies in multi-dose experiments including active control. Statistics in Medicine P 11, l 220. Since this is an estimate rewrite as: [...estimate an incidence of...]. Leave out true. 10. P 12, l 258 and 259. Replace [principle] with [principal]. Also P 22, left column, second dash, l P 18 ff. BMC Trials likes to the first 30 authors before using [et al]. So please add authors to R(eference)s 7, 9, 14, 18, 20, 12. P 20, R 16, last l. Insert [(German)]. Include the language of the original article. 2

4 13. P 20, R 23. Delete [In] and add a location where this document can be found. Also for R 27 and 28 on P P 22, right column, fourth dash, l 1. Rewrite as [> 38]. There is always a space between inequalities and numbers. See also P 23, right column, bullet 4, dash 2, l 1 and dash 4 lines 1 and Consider adding the short forms for laboratory tests from P 26 into P 15. CHANGE: The laboratory tests were spelled out. Therefore, there is no need for extending the abbreviation list. Editorial requests: 1. Please ensure the title conforms to journal style for study protocol articles. The title should follow the format? : study protocol for a randomized controlled trial.? Please note that the title in the submission system should match that of your manuscript. 2. Please include the date of registration with the trial registration number at the end of the Abstract. 3. Please include the names of all ethical bodies that approved your study in the various centres involved. If you do not wish to list them all in the Methods section, please include the list as an additional file and refer to this in the Methods section. 4. Please include a statement in your Methods section explaining that you obtained informed consent from each participant. 5. Please state clearly whether or not you have funding in the Acknowledgements section. If there is no funding, please state this. : The trial is funded by the Deutsche Forschungsgemeinschaft (grant number KA 3104/2-1 ) 6. Please mention each author individually in your Authors? Contributions section. We suggest the following kind of format (please use initials to refer to each author's contribution):?ab carried out the molecular genetic studies, participated in the sequence alignment and drafted the manuscript. JY carried out the immunoassays. MT participated in the sequence alignment. ES participated in the design of the study and performed the statistical analysis. FG conceived of the study, and participated in its design and coordination and helped to draft the manuscript. All authors read and approved the final manuscript.? 7. Please include a figure title and legend section after the reference list. 3

5 8. For additional files, please ensure that you list the following information after your reference section in your manuscript: 4