outcome; describe deviations from planned study protocol, together with reasons Dates defining the periods of Recruitment 14 recruitment and follow-up Baseline demographic and Baseline data 15 clinical characteristics of each group Number of participants (denominator) in each group Numbers 16 included in each analysed analysis and whether analysis was by
outcome; describe deviations from planned study protocol, together with reasons Recruitment 14 Dates defining the periods of recruitment and follow-up Baseline data 15 Baseline demographic and clinical characteristics of each group Numbers analysed 16 Number of participants (denominator) in each group included in each analysis and whether analysis was by
CONSORT%20Extension%20for%20Pragmatic%20Trials%20Checklist.docx