Ninety participants were eliminated from the per protocol immunogenicity cohort for HI for non-compliance with the protocol.
Of these, 239 successfully completed the trial, and one subject in the 3 8 year, 7.5 µg group was withdrawn at the Day 21 visit, before the second vaccination, for non-compliance with the protocol.
Non-compliance with medication, protocol violation or unreliable behaviour.
Study treatment continued until: disease progression; unacceptable toxic effects; the patient or physician requested discontinuation; or serious non-compliance with the protocol.
To ensure that the data reflected actual levels of physical activity in the participants, detailed screening procedures were conducted to detect non-compliance with the protocol.
Many withdrawals were not vaccine-related, most being due to employment commitments, overseas relocation or non-compliance with the protocol as a result of pregnancy.
Furthermore, in each study-group one patient discontinued the study due to non-compliance with the protocol (not willing to undergo blood sampling).
This difference may arise from the inclusion of data from participants who withdrew from the trial because of ineffective therapy, non-compliance with the protocol, adverse events, or other reasons.
NSAIDs were discontinued for 2 10 days before surgery in only 40% of the hospitals; non-compliance with this protocol was a reason for cancellation of surgery in only 10% of the departments.
These include: omission of more than 3 following dosages, voluntary discontinuation by the patient, safety reasons as judged by the study physician or treating physician, or significant non-compliance with the protocol as judged by the study physician.
*Split catheter (1), flow problems or blocked catheter (5), intensive care admission unrelated to the trial (1), patient request (4), reduced to twice weekly dialysis (2), not specified (1), relocation to a non trial site (1), non-compliance with trial protocol (1), deceased (1), ethanol supply temporarily ceased (1).
