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If this is an RCT, please consult the SPIRIT guidelines for preparing your study protocol and address as many of these items as possible with your expression of interest. Please describe your research question in terms of the PICO structure (Population, Intervention, Comparator,Outcome measures (efficacy and harms) and for each of these explain their rationale. You should be aware of any ongoing RCTs aiming to address this or similar question/s. Check trial registers such as clinicaltrials.gov/ISRCTN Your trial might not be quite ready for an RCT, if so, please identify at what stage pre-RCT you are at. If you are developing a new surgical technique or evaluating a new device please consult the IDEAL Framework (www.ideal-collaboration.net/) and see attached summary to identify stage of development and appropriate methodology.
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