The study was considered non-localizing if no cluster was found that could fit the IOZ.
The study was considered exempt from review by the hospital IRB.
The study was considered to be part of routine care, and the need for written informed consent was waived.
The study was considered complete after stage 1 because the power of the study was > 90% for AUC0-inf with α = 0.05.
The study was considered exempt from institutional review board evaluation on the basis of federal regulation 45 CFR 46.101(b) (research involving the study of existing data recorded in such a manner that subjects cannot be identified).
The study was considered as part of a routine program for TBRF diagnosis that could improve this diagnosis for future cases of TBFR and its control.
The study was considered an audit of standard practice.
The study was considered exempt by the Colorado Multiple IRB (COMIRB).
The study was considered an audit and informed consent was waived.
The study was considered hypothesis-generating; a power calculation was therefore not performed.
The study was considered positive if both primary end points were met.
