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A simulation study was conducted that resulted in the development of the necessary sample size for the studies in addition to identifying a decision algorithm that was prospectively defined in the protocols.
For instance, we wondered whether the interests or constraints of authors carrying out large multicentre trials funded by industry would differ from those of authors carrying out small investigator driven trials and whether this would result in discrepancies in the study populations defined in the protocols and subsequent trial reports.
It should be noted here that length of stay and duration of treatment were only two of several measured health outcomes, and that their reduction were not prospectively defined in the protocols of the two clinical trials on which these economic analyses were based.
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This step searches for studies by following the search method defined in the protocol.
It is also compliant with the functionalities defined in the protocol.
The detailed structure of the content depending on message types is defined in the protocol specification [14].
The parameter m is defined in the protocol which means the contention window is kept as C W max when times of backoff are no less than m.
Secondary outcomes (time to event) were; moderate-to-severe anaemia (defined as Hb <8 g/dL) and all-cause hospitalizations in the first year of life, as defined in the protocol.
The numbers analyzed for safety and immunogenicity included those volunteers meeting all eligibility criteria, complying with the procedures defined in the protocol, and for whom results were available after receiving at least one study vaccination.
The primary analysis for immunogenicity was conducted on the ATP cohort for immunogenicity, defined as all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
The primary analysis for efficacy was conducted on the ATP cohort for efficacy defined as all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy endpoint measures were available.
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