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We searched MEDLINE, the Cochrane Methodology Register, and the Cochrane Database of Systematic Reviews (limited to reviews) up to September 2009, and EMBASE up to August 2007.

We searched reference lists, Pub Med “related articles,” and citation searches using SCOPUS to identify additional relevant studies.

Rather, we call for a transparent and complete description of what is intended, regardless of the characteristics or quality of the plans.

The SPIRIT 2013 Statement addresses the minimum content for interventional trials; additional concepts may be important to describe in protocols for trials of specific designs (eg, crossover trials) or in protocols intended for submission to specific groups (eg, funders, research ethics committees/institutional review boards).

For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance.

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.

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.




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