The summary of the results of the clinical trial for laypersons shall contain information on the following elements:

1. 1.

   Clinical trial identification (including title of the trial, protocol number, EU trial number and other identifiers);

2. 2.

   Name and contact details of the sponsor;

3. 3.

   General information about the clinical trial (including where and when the trial was conducted, the main objectives of the trial and an explanation of the reasons for conducting it);

4. 4.

   Population of subjects (including information on the number of subjects included in the trial in the Member State concerned, in the Union and in third countries; age group breakdown and gender breakdown; inclusion and exclusion criteria);

5. 5.

   Investigational medicinal products used;

6. 6.

   Description of adverse reactions and their frequency;

7. 7.

   Overall results of the clinical trial;

8. 8.

   Comments on the outcome of the clinical trial;

9. 9.

   Indication if follow up clinical trials are foreseen;

10. 10.

    Indication where additional information could be found.