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Table 7 LIONESS trial flowchart of visits and procedures

From: Design and rationale for the randomised, double-blinded, placebo-controlled Liraglutide to Improve corONary haemodynamics during Exercise streSS (LIONESS) crossover study

  Screening visit Commence trial (Week 0) Study visit (Week 1) Exercise test 1 (Week 2) Exercise test 2 (Week 3) Study visit (Week 4) Exercise test 3 (Week 5) Exercise test 4 (Week 6)
Obtain informed consent, issue safety information card and patient diary Yes - - - - - - -
Randomisation to study agents Yes Perform first self-administration of study agent - - - - - -
Issue 7-day course of blinded study agent - Yes Yes Yes Yes Yes Yes Stop all study medication
Check study drug compliance - - Yes Yes Yes Yes Yes Yes
Withdraw protocol-mandated pre-existing patient medication Tutorial and commence withdrawal Complete withdrawal - - - - - Recommence pre-existing patient medication
Home Blood Glucose Monitoring Tutorial and issue equipment - Record data from patient diary Record data from patient diary Record data from patient diary Record data from patient diary Record data from patient diary Record data from patient diary
Physical examination Yes Yes Yes Yes Yes Yes Yes Yes
Height measurement Yes - - - - - - -
Weight measurement Yes Yes Yes Yes Yes Yes Yes Yes
Blood pressure measurement Yes Yes Yes Yes Yes Yes Yes Yes
Electrocardiogram Yes - - - - - - -
Pre-specified blood tests Yes Yes Yes Yes Yes Yes Yes Yes
Perform supervised exercise tolerance test (ETT) Yes (if recent ETT unavailable) - - Yes Yes - Yes Yes