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Ethics declarations Competing interests MES and DJP were full-time employees of Janssen Pharmaceutica NV during the execution of the study

Integration of patient-reported outcomes (PROs) into both research and clinical care can provide invaluable insights into the subjective burden of treatment and inform more responsive, patient-centered management strategies

A study of the particular drivers of enrollment differences is warranted, adjusting for unique demographic profiles of multicountry trials (as population demographics in most regions of the world are very different from the U.S

[13] In addition to the four-year prison term, U.S