However, due to noncompliance with protocol requirements, meal-test endpoints for seven individuals were excluded from the analysis.
Patient noncompliance with protocol procedures, or unwillingness or inability to continue the trial was also a reason for patient removal from the trial.
Among all patients who discontinued study treatment (n = 43), the most common reason for discontinuation was noncompliance with protocol (n = 13; Figure 1).
Criteria for removal from the study included: (1) patient noncompliance with protocol requirements, (2) unacceptable adverse reaction, (3) patient's wishes, (4) belief that the constraints of the study were detrimental to the patient's health, and (5) inpatient status on day(s) planned for the 99mTc-EC-DG scans.
Noncompliance with the protocol was an important confounder.
Sixty-six E2/U2, probable FAs were biopsied due to noncompliance with the protocol.
Before database lock, it was decided to exclude five patients from all analyses because of serious noncompliance with the protocol.
A number of factors are known to result in complications after total knee arthroplasty (TKA), which include preoperative deformity, neuromuscular disease, patient noncompliance with rehabilitation protocol and technical errors such as component malpositioning [ 1- 4].
After 8 weeks, the EPA levels of these two patients had risen further (2.8 and 3.1%) and two more of the 12 patients in the control supplement group had levels of EPA >1.6%, thereby suggesting consumption of EPA from a source outwith the trial, and indicting noncompliance with the protocol.
Thus, the national availability of the RePAIR program for remediation may address demonstrated needs of research-intensive institutions as they address wrongdoing in research, including persistent noncompliance with approved research protocols.
In October, lawyers for the organization unsuccessfully went before the Federal Court of Appeal to challenge a lower court's refusal to hear its case against the government for noncompliance with the Kyoto Protocol Implementation Act.
