Paragraph 31 Format of the abstract of the final study reportF1

title, with subtitles including date of the abstract and name and affiliation of main author;

keywords (not more than five keywords indicating the main study characteristics);

rationale and background;

research question and objectives;

study design;

setting;

subjects and study size, including dropouts;

variables and data sources;

results;

discussion (including, where relevant, an evaluation of the impact of study results on the risk–benefit balance of the product);

name of holder; and

names and affiliations of principal investigators.