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We used piloted forms to screen and extract data relevant to specific checklist items.

When citing empirical evidence in the E&E, we aimed to reference a systematic review when available.

To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials).

The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial 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.

The main outputs are the SPIRIT 2013 Statement,14 consisting of a 33 item checklist of minimum recommended protocol items (table 1The SPIRIT 2013 Statement and E&E paper reflect the collaboration and input of 115 contributors, including trial investigators, healthcare professionals, methodologists, statisticians, trial coordinators, journal editors, as well as representatives from research ethics committees, industry and non-industry funders, and regulatory agencies.

Details of the scope and methods have been published elsewhere.13 14 15 Briefly, three complementary methods were specified beforehandin line with current recommendations for development of reporting guidelines16: 1) a Delphi consensus survey15; 2) two systematic reviews to identify existing protocol guidelines and empirical evidence supporting the importance of specific checklist items; and 3) two face-to-face consensus meetings to finalise the SPIRIT 2013 checklist.

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials.