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To identify examples for each checklist item, we obtained protocols from public websites, journals, trial investigators, and industry sponsors.

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When citing empirical evidence in the E&E, we aimed to reference a systematic review when available.We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols.Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.Furthermore, the checklist was pilot tested by graduate course students, and an implementation strategy was developed at a stakeholder meeting.The SPIRIT recommendations are intended as a guide for those preparing the full protocol for a clinical trial.When no review was identified, we either cited all relevant individual studies, or if too numerous, a representative sample of the literature.

Some items had little or no identified empirical evidence (eg, title) but their inclusion in the checklist is supported by a strong pragmatic or ethical rationale.

If information for a recommended item is not yet available when the protocol is being finalised (eg, funding sources), this should be explicitly stated and the protocol updated as new information is obtained.

Formatting conventions such as a table of contents, glossary of non-standard or ambiguous terms (eg, randomisation phase or off-protocol), and list of abbreviations and references will facilitate understanding of the protocol.

Proper names of trial personnel have been abbreviated with italicised initials, and any reference numbers cited in the original quoted text are denoted by [] to distinguish them from references cited in this E&E paper.

For each checklist item we also strived to provide references to empirical data supporting its relevance, which we identified through a systematic review conducted to inform the content of the SPIRIT checklist.

This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations.