Selection and Description of Participants:
Describe your selection of the observational or experimental participants (patients or laboratory animals, including controls) clearly, including eligibility and exclusion criteria and a description of the source population. Because the relevance of such variables as age and sex to the object of research is not always clear, authors should explain their use when they are included in a study report; for example, authors should explain why only subjects of certain ages were included or why they excluded a gender from the study.
The guiding principle should have clarity about how and why a study was done in a particular way. When authors use variables such as race or ethnicity, they should define how they measured the variables and justify their relevance.
Identify the methods, apparatus (give the manufacturer's name and address in parentheses), and procedures in sufficient detail to allow other workers to reproduce the results. Give references to established methods, including statistical methods; provide references and brief descriptions for methods that have been published but are not well known; describe new or substantially modified methods, give reasons for using them, and evaluate their limitations. Identify precisely all drugs and chemicals used, including generic name(s), dose(s), and route(s) of administration.
Reports of randomized clinical trials should present information on all major study elements, including the protocol, assignment of interventions (methods of randomization, concealment of allocation to treatment groups), and the method of masking (blinding), based on the CONSORT Statement (http://www.consort-statement.org).