One could further hypothesise that other emergency situations in other settings would have a similar effect because emergencies lead to time pressure and time pressure reduces the likelihood of complying with protocols that take extra time.
All subjects agreed to comply with protocol requirements and provided written informed consent.
This suggests that doctors working in the hospital in Kassena-Nankana districompliedied with protocol standards of prescription, as has been reported in Sudan [ 40].
In rural Malawi, inability to afford transport costs related to the long distances to hospitals has been cited as impeding the ability to comply with protocol [ 21].
Patients were required to give written informed consent before study-specific procedures were performed and to comply with protocol for the duration of the study.
All subjects were eligible to enroll in the extension study if they completed the CONQUER study on treatment and complied with protocol requirements.
If patients did not comply with protocol because of various reasons like as conversion of surgical type, total resection and follow up loss, then they will be excluded from the per-protocol (PP) group.
The primary analysis of immunogenicity was conducted on the according-to-protocol (ATP) immunogenicity cohort comprising subjects who complied with protocol defined procedures and criteria, who received the challenge hepatitis B vaccine dose, and for whom immunogenicity data were available.
In particular, by obtaining support from opinion leaders we sought to create greater expectations for clinicians to comply with protocol behaviour from their peers and colleagues, affecting change in social norms [ 19].
Immunogenicity analyses were performed on the month 48 ATP-I in the HPV vaccine group, wherein women received all 3 vaccine doses, complied with protocol procedures, and did not acquire HPV-16 or HPV-18 infection during the study.
The ATP-E included women, who received all 3 vaccine doses, complied with protocol procedures, were negative for HPV-DNA of the type analyzed at month 0 and 6, and had a normal or low-grade cytology at baseline.
