✚ What does the lay summary include? The clinical trial lay summary will contain the following ten elements. ✚ Element 1 Clinical trial identification (including title of the trial, protocol number, EU trial number and other identifiers) ✚ Element 2 Name and contact details of the sponsor ✚ Element 3 General information about the trial (where and when it was conducted, main objectives, and an explanation of the reasons for conducting it) ✚ Element 4 Population of patients (number from Member State concerned, the Union and third countries; age and gender breakdown; inclusion/exclusion criteria) ✚ Element 5 Investigational medicinal products used ✚ Element 6 Description of adverse reactions and their frequency ✚ Element 7 Overall results of the clinical trial ✚ Element 8 Comments on the outcome of the clinical trial ✚ Element 9 Indication if follow-up clinical trials are foreseen ✚ Element 10 Indication where additional information can be found
