Table 5 Items requested in the continuing review report

Number of persons enrolled

35

89.7

Gender and ethnic/religious breakdown of enrolled persons

24

61.5

Number of persons withdrawn from the research by the investigators

35

89.7

Withdrawal reasons

34

87.2

Number of persons who dropped out of the research

34

87.2

Reasons why persons dropped out

32

82.1

Verification that all persons gave their informed consent and that all signed consent forms are on file

31

79.5

Number and description of serious adverse events in the previous year

36

92.3

List of any protocol violations or deviations

34

87.2

Any safety monitoring reports

36

92.3

If the study is finalised, submission of a final report describing the study outcomes

36

92.3