The ECG may vary during the day (intra-day), and between days (interday), for the same subject. Variability in ECG characteristic measurements between different investigators is well documented and is often large. During days 1-6 of each placebo period of a two-way crossover Phase I study, digital ECGs were recorded at about 8 and 12 AM in 16 healthy volunteers (8 men, 8 women).
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