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We shoot the pictures and video ourselves which means it's unique.We think you'll find our orgasm erotica rather special.This E&E paper provides important information to facilitate full understanding of each checklist item, and is intended to be used in conjunction with the SPIRIT 2013 Statement.14 These complementary tools serve to inform trial investigators about important issues to consider in the protocol as they relate to trial design, conduct, reporting, and organisation.To identify examples for each checklist item, we obtained protocols from public websites, journals, trial investigators, and industry sponsors.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).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.Additional examples are also available on the SPIRIT website (The availability of examples for all checklist items indicates the feasibility of addressing each recommended item in the main protocol rather than in separate documents.

Modelled after other reporting guidelines,17 18 this E&E paper presents each checklist item with at least one model example from an actual protocol, followed by a full explanation of the rationale and main issues to address.

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.

Furthermore, the checklist was pilot tested by graduate course students, and an implementation strategy was developed at a stakeholder meeting.

The recommendations are not intended to prescribe how a trial should be designed or conducted.

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

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