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For the KETO study, a clinical trial application was submitted and Medicines and Healthcare products Regulatory Agency approval to conduct the study was obtained before the first subject was screened.
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As well as seeking explicit references to trial registration, we looked to see whether journal instructions mentioned the Declaration of Helsinki because the most recent (2008) version states that "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject".
Fitch called for the first subject.
Take the first subject.
In the initial study design, all subjects were to be vaccinated on Day 0 and Day 21, however, the protocol was amended soon after the enrolment of the first subjects (and before Day 21 was reached for these subjects) to include a Day 0 and Day 182 immunization schedule.
Subjects attended a screening visit, performed 1 2 weeks before the first study day, to confirm eligibility.
During the 3 d before the first trial, subjects recorded all of the food and drink that they consumed and repeated this diet before the second trial.
Details of the trial were registered at http://www.trialregister.nl NTR2322) before first subject enrolment.
Five of these six subjects with DENV-4 viremia were unprimed before the first vaccination (four subjects in the F17/Pre group and one subject in the F17 group).
In an additional exercise session, at least 1 week before the first visit, the subjects' one-repetition maximum (1-RM) was determined (Kraemer and Fry 1995).
At least 5 days before the first experimental day, subjects performed a VO2 max test on a cycle ergometer using a standard progressive exercise test.
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