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The core study population comprised adult (18 70 years) de novo recipients of a liver transplant from a deceased or living donor.
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One patient was excluded from the ITT population because of unknown implant allocation during the core study (n = 48, ITT population).
Furthermore, one patient could not be analysed according to the PP population, because one of the two implants was lost and replaced during the core study (n = 47, PP population).
The major limitation of this study is the inability to evaluate the hepatitis B core antibody (antiHBc) in our study population due to low budget and limited resources.
The study population for the core module comprised adults aged 18 years and over who lived in private residential accommodation within a defined road network distance buffer around one of the core Connect2 case study sites (see below) and whose names appeared on the edited electoral register (ER) held by the relevant local authority.
This hierarchical sampling or recruitment strategy offers the advantage of both samples (i.e., the core and the detailed samples) being selected from the same finite study population.
A large study population, accurate data collection, and mapping of individual cores of the TTPM biopsies for every patient added strength to the study.
The core module FACT-G also showed a ceiling effect when applied to other types of cancer patients from the same study population [ 17].
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