20:T516,In response to overwhelming evidence and the consequences of poor-quality reporting of randomized, controlled trials (RCTs), many medical journals and editorial groups have now endorsed the CONSORT (Consolidated Standards of Reporting Trials) statement, a 22-item checklist and flow diagram. Because CONSORT primarily aimed at improving the quality of reporting of efficacy, only 1 checklist item specifically addressed the reporting of safety. Considerable evidence suggests that reporting of harms-related data from RCTs also needs improvement. Members of the CONSORT Group, including journal editors and scientists, met in Montebello, Quebec, Canada, in May 2003 to address this problem. The result is the following document: the standard CONSORT checklist with 10 new recommendations about reporting harms-related issues, accompanying explanation, and examples to highlight specific aspects of proper reporting. We hope that this document, in conjunction with other CONSORT-related materials (http://www.consort-statement.org), will help authors improve their reporting of harms-related data from RCTs. Better reporting will help readers critically appraise and interpret trial results. Journals can support this goal by revising Instructions to Authors so that they refer authors to this document.21:T40d,Studies on man and lower animals have shown that the cranial blood vessels are pain-sensitive structures, capable under special circumstances of giving rise to headache.¹The distention of cerebral arteries is primarily responsible for the headache produced by certain chemical agents, of which histamine is representative;²the headache associated with septicemia and fever is in the same category.³It has been shown that the afferent fibers from the pain-sensitive cerebral arteries above the tentorium enter the brain stem primarily through the fifth cranial nerve, whereas the fibers from the arteries below the tentorium enter the nervous system chiefly through the upper cervical nerves.⁴The distention of certain branches of the external carotid arteries is chiefly responsible for migraine headache and the headache associated with arterial hypertension.⁵ Thus, data about the great variety of headaches resulting from distention of cranial arteries are specific, but there is

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