Screen

1. Heart Rate x Heart Rate B Heart Rate x Definition: e.g Heart Rate, systolic/diastolic bp etc, what it is and relationship to e.g. pulse. Definition (planned) Context: how measured (e.g. = type of instrument) and qualifiers (e.g sitting, standing, supine, angle, units etc) Definition Actual context for an individual (actually standing even though supposed to be sitting, Never seen this but conceivable (e.g. lab samples, hemolysed/broken samples, thawed/ -80 instead of -20 etc) Trial (planned) context: Screening vs baseline vs final, vs safety baseline vs efficacy baseline, vs arm of the trial. Position relative to planned active treatment, planned tests (e.g. element/visit of the trial). Patient (actual) context: relative to actual active treatments, medical history, adverse events, concomitant medications, genotype etc. Last observation carried forward, Intent to treat, evaluable. Days from planned. S = screening HR A = baseline HR for safety A & C = efficacy HR baselines B & D = efficacy final HR Heart Rate C Heart Rate A Heart Rate S Screen Run In Treat A Wash Out Treat B Final Arm AB Heart Rate x Heart Rate D Heart Rate x