Table 1 Definition of exploratory endpoints

Time-normalized sum of symptom severity scores

For every day of recorded HAE symptoms, the patient was to grade the severity of each symptom as mild = 1, moderate = 2, or severe = 3

The time-normalized sum of these severity scores for every day of recorded symptoms per patient was calculated as

\(\frac{{{\text{Sum}}\,{\text{of}}\,{\text{severity}}\,{\text{scores}}\,{\text{for}}\,{\text{every}}\,{\text{day}}\,{\text{of}}\,{\text{recorded}}\,{\text{HAE}}\,{\text{symptoms}}\, ( {\text{yes)}}\,{\text{in}}\,{\text{treatment}}\,{\text{period}}}}{{{\text{Number}}\,{\text{of}}\,{\text{days}}\,{\text{with}}\,{\text{entered}}\,{\text{HAE}}\,{\text{symptoms}}\, ( {\text{yes/no)}}\,{\text{in}}\,{\text{treatment}}\,{\text{period}}}}\)

Time-normalized sum of symptom severity scores combined with rescue medication use

The time-normalized sum of symptom severity scores for every day of recorded HAE symptoms combined with the number of uses of rescue medication was defined and calculated as follows

Rescue medication was coded as 1 if no rescue medication was taken and 2 if any rescue medication was taken

The symptom severity score for each day of recorded HAE symptoms was multiplied by the rescue medication code to give a combined value

The combined values from all days of recorded HAE symptoms during the treatment period were summed

The summed value was divided by the number of days of entered HAE symptoms (yes/no) in the treatment period