2.1 Primary objective .......................................................................................................................................... 8

2.2 Secondary objective ...................................................................................................................................... 8

2.3 Study design.................................................................................................................................................. 9

2.4 Planned sample size .................................................................................................................................... 11

3.1 Background details ..................................................................................................................................... 12

3.2 Deviations from the trial protocol with regard to statistical analyses ......................................................... 12

3.3 Individual protocol deviations .................................................................................................................... 12

4.1 Safety population ........................................................................................................................................ 13

4.2 Full analysis set population ......................................................................................................................... 13

4.3 Per-protocol population .............................................................................................................................. 13

4.4 Subgroup analyses ...................................................................................................................................... 13

5.1 Conventions ................................................................................................................................................ 14

5.1.1 Baseline definition ........................................................................................................................... 14

5.1.2 Missing data ..................................................................................................................................... 14

5.1.3 Pooling of centers ............................................................................................................................. 15

5.2 Demographic and other background data ................................................................................................... 15

5.2.1 Basic description .............................................................................................................................. 15

5.3 IMP exposure, compliance ......................................................................................................................... 16

5.4 Medical history, physical examination ....................................................................................................... 16

5.5 Prior and concomitant medication .............................................................................................................. 16

5.6 Concomitant non-pharmacological measures, pre-medication ................................................................... 16

5.7 Efficacy ....................................................................................................................................................... 17

5.7.1 Primary endpoint .............................................................................................................................. 17

5.7.2 Secondary endpoints ........................................................................................................................ 18

5.8 Pharmacokinetics / Pharmacodynamics ...................................................................................................... 19

5.9 Safety .......................................................................................................................................................... 19

5.9.1 Adverse events ................................................................................................................................. 19

5.9.2 Vital signs ........................................................................................................................................ 20

5.9.3 Safety laboratory variables ............................................................................................................... 20

5.10Other variables ............................................................................................................................................ 20

5.11Interim analyses .......................................................................................................................................... 21

8.1 Formulas for derived variables ................................................................................................................... 22

8.2 List of Tables, Listings, Figures ................................................................................................................. 22

Quality Control

sICAM

•

•

•

•

•

•

•

•

•

•

•

•

•

NOTES: * screening period lasts up to 7 days but can be extended to max 30 days in case of re-testing of sUA. sUA can be

re-tested if current sUA level is changed due to acute (transient) condition as it is not in line previous medical data as per

investigator opinion and approval from the Sponsor.

•

•

•

•

•

•

•

•

α

α

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•

•