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The post-challenge ATP immunogenicity analysis was performed on children who complied with the protocol for the challenge part of the study and for whom assay results were available for antibodies against at least one study vaccine antigen one month post the challenge dose.
A main researcher supervised the measurements to ensure physiotherapists complied with the protocol.
Only patients who fully complied with the protocol were included in the final analysis.
28 of the 41 (68%) patients complied with the protocol over a four-month period.
In 65.8% of the 1,168 observations of patient contacts requiring hand hygiene, healthcare workers fully complied with the protocol.
In total 1,168 direct observations of events requiring hand hygiene were analysed; in 65.8% of cases healthcare workers fully complied with the protocol.
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Immunogenicity analyses were performed on the according-to-protocol (ATP) immunogenicity cohort, defined as vaccinated subjects who met all eligibility criteria, complied with the protocol-defined procedures and with at least 1 antibody assay result available.
At each time point, the ATP cohort included all evaluable subjects who met eligibility criteria, who complied with the protocol-defined procedures, who were not eliminated during the study and for whom data concerning immunogenicity measures were available.
All animal procedures complied with the protocols approved by the Institutional Animal Care and Use Committee at the University of Colorado.
The research complied with the protocols established by the China Wildlife Conservation Association and adhered to the American Society of Primatologists (ASP) Principles for the Ethical Treatment of Non-Human Primates as well as the legal requirements of China.
To overcome such a problem, a motivational mechanism is needed to incentivize vehicles to comply with the protocol design in such distributed networks.
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