In addition, we performed analysis with additional adjustments for residential area (county), leisure time physical activity, anti-citrullinated protein/peptide antibodies (ACPA -status, treACPA -statusseline, and streatmente.
In addition to all the analyses above, we performed analysis with extra adjustments for residential area, leisure time physical activity, ACPA-status, treatment at baseline and study phase, but the results did not alter substantially and those variables were not kept in the final analyses.
Overall, there was no statistically significant difference in mean number of subjects recognized as problem drinkers by faculty and residents across baseline and study phases.
Overall, comparative analysis of mean number of patients given advice to reduce drinking by faculty and residents across baseline and study phases did not demonstrate statistically significant changes.
Analysis of variance (ANOVA) was used to compare differences between faculty and residents across baseline and study phases for the study's three primary outcome measures – mean number of subjects recognized with problem drinking, level of certainty in recognition, and number of patients given advice to reduce drinking.
The primary covariates used in the trial were World Health Organisation (WHO) performance status, chemotherapy received, baseline liver function and study phase; these were balanced between treatment arms and are described elsewhere (Hoff et al, 2012).
For the biomarker analysis, HRs were derived from a Cox proportional hazards model with covariates for World Health Organisation (WHO) performance status, chemotherapy received (HORIZON II only), baseline liver function and study phase (i.e., whether or not patients contributed to an end-of-Phase II analysis in the HORIZON programme; HORIZON II only).
However, since the individual difference in MSF during baseline and during study phase 1 was used to evaluate clinical efficacy, this baseline difference had little influence on the primary efficacy outcome.
Paired t tests were used to examine whether mean changes from baseline to the end of study phase 1 and mean changes from baseline to study phase 2 were significantly different from zero.
Treatment failures were withdrawn from the study if they fulfilled both of the lack of therapeutic effect discontinuation criteria: (1) 30% or more worsening from baseline of this study phase on DSM-IV ADHD rating scale score AND; (2) less than 30% remaining improvement from the phase 1 baseline score on DSM-IV ADHD rating scale.
Despite the fact that two decades had passed since the baseline study phase, we were able to track 80% of the initial group of 1773.
