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Immunogenicity analysis was performed on the according-to-protocol (ATP) cohort which included all participants for whom prevaccination and postvaccination serology results were available and who complied with study procedures.
The according-to-protocol (ATP) cohort for immunogenicity (all subjects who met all eligibility criteria, received 3 vaccine doses and complied with study procedures) comprised 421 women (205 women in the HPV-16/18 HPV-16/18roup and 216 in the HPvaccine16/18 vaccine group).
The immunogenicity analysis was performed on the ATP cohort, which included all children for whom pre- and post-dose-1 vaccination serology results were available, who were seronegative for at least one vaccine antigen before vaccination and who complied with study procedures.
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Exclusion criteria were trauma within 7 days, chronic headache defined as > 3 months duration, age < 18 years, missing informed consent, and inability to comply with study procedures due to insufficient knowledge of the German language.
Other reasons for ineligibility in both protocols accounted for 7.9% of the exclusions and included reports of high-risk behavior for HIV infection (5), inability to comply with study visit schedules (3), and pregnancy (1).
At the screening visit, women were interviewed to confirm understanding and willingness to comply with study requirements, completed written informed consent, received HIV pretest and condom counseling, and underwent oral mucosal transudate (OMT) rapid HIV testing.
Rather, unemployment may correlate with an increased availability to comply with study visits and procedures.
Willing and able to comply with study requirements, timing and nature of required assessments.
Participant is unable to comply with study insulin pump and/or CGM during run-in period.
Inability, in the opinion of the investigator, to comply with study requirements.
52 However, these strategies are not a sign that study participants do not want to comply with study requirements.
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