11.   There will be one or more events resulting from this decision, over which the project leader has no control but for which probability assessments can be made.

12.   The emphasis here was placed on the need for a thorough self-appraisal of this issue before an outsider could make any assessment.

13.   Because endoscopic follow up was inconsistent, we did not attempt to make an assessment of endoscopic disease activity during the treatment period.

14.   All assessments were made without knowledge of the treatment group.

15.   The histological assessments were made without knowledge of either patient group or the order of biopsies.

16.   In all three groups, dietary assessments were made before starting treatment and again at each follow up visit.

17.   Histopathology assessments were made without knowledge of the endoscopic or biochemical findings.

18.   This includes the user associated with the DC, who must also make an assessment.

19.   This gives the assessors some idea of how quickly they must make their assessments.