Subjects were evaluated before each injection of study drug, at study day 150, which corresponded to 30 days after the fifth and final planned dose of study drug, and at the final follow-up visit between study days 270 and 300, which corresponded to 120 to 150 days after the fifth dose of study drug.
All patients gave written informed consent prior to participation in the original study and before continuation in each study extension.
We calculated natural log (ln) risk ratios separately within each study before pooling them across studies by random effects meta-analysis. 3 For prospective cohort studies, we used stratified Cox proportional hazard regression models to calculate hazard ratios for incident coronary heart disease risk.
The protocol, the patient information and consent form, and other relevant study documentation were approved by the Institutional Review Board IRBB) for each study center before initiation of the study.
The appropriateness of the study was reviewed and approved by the Institutional Review Board at each study center, before initiating the study.
Written informed consent was obtained from each study subject before interview, and the study was approved by the US National Cancer Institute and local institutional review boards.
The protocol and consent forms were approved by the Institutional Review Board at each study site before study initiation, all patients signed a written informed consent before enrollment, and the study was conducted in accordance with Good Clinical Practices.
The study was approved by the Institutional Review Board of each study site before the study was initiated and was carried out in accordance with the Declaration of Helsinki and the principles of Good Clinical Practice (set forth by the International Conference on Harmonisation E6 requirements).
Written informed consent was obtained from each study participant before the initiation of the study.
At each study site, the international clinical study team provided training six weeks before study initiation on the clinical study protocol.
It is easy to see that the kernel functions that were studied before are included in our study.
