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The primary publication for the trial will follow CONSORT guidelines for randomized controlled trials.
The primary publication for the trial will follow CONSORT guidelines for cluster randomised controlled trials.
Baseline demographics were reported in the primary publication for this study [ 8].
Study design and patient inclusion and exclusion criteria are described in the primary publication for this study [ 10].
The main objectives of the study, which are reported in the primary publication for this study [ 7], were to collect detailed background data on the population of patients hospitalized with CAP in Europe, to provide a summary of clinical practice decisions in these patients and to understand the impact of these decisions in terms of rates of initial antibiotic treatment modification and mortality.
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The use of published data is, we suggest, a strength of this study: it establishes the independence of the data from the authors and adds transparency by allowing interested readers to peruse the primary publications for further methodological specifics as required.
Detailed study design information, including inclusion and exclusion criteria, can be found in the primary publications for the nizatidine and amantadine studies [ 13, 14] and in the CTR summary for the sibutramine study (, Trial ID: 5102).
Clinical and Translational Medicine is also proud to be affiliated with the newly established International Society of Translational Medicine (ISTM) [10] and will be a primary publication site for clinical and translational science and research associated with ISTM.
23 The data at the 3 year time point for the two phase 3 trials were mostly identical in the regulatory documents and primary publications except for non-vertebral fractures for both SOTI and TROPOS (table 2).
Data from substudies will not be submitted for publication until the primary publication, the LIVE study, has been accepted for publication.
Data for the primary publication will be analyzed exclusively by the Methods Centre.
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