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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.
Acute effective therapy was defined in the protocol as pain relief (decrease in categorical pain scale (CPS) from 2 (moderate) or higher to 1 (mild) or 0 (none)) without the use of acute medications or pain freedom (decrease in CPS from 1 (mild) or higher to 0 (none)) without the use of acute medications as evaluated immediately following the cessation of SPG stimulation.
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.
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 ATP cohort for analysis of immunogenicity included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol, having no elimination criteria during the study) for whom data concerning immunogenicity endpoint measures were available.
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.
No a priori subgroups were defined in the protocol.
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