Study design
POLAND, APPENDIX
PARALLEL‐303 was a double‐blind, placebo‐controlled, randomized, multicenter, global phase 2 study (NCT03427814). This study changed from phase 3 to a phase 2 due to slow enrollment. Patients were recruited from 138 sites across 16 countries/regions (Australia, Belgium, China, Czech Republic, France, Georgia, Hong Kong, Hungary, Japan, Poland, Russia, Singapore, Spain, Taiwan, the United Kingdom, and the United States). All relevant Institutional Review Boards/Independent Ethics Committees approved this study, which was carried out in accordance with the International Conference on Harmonization Good Clinical Practice Guideline, the principles of the Declaration of Helsinki, and local laws and regulations. The full protocol (including eligibility criteria, endpoints, assessments, and statistical plan) is available in the Appendix 