Aernoud Fiolet

296 Chapter 12 RESULTS Patients Trial enrolment began on October 27, 2016 and continued until November 3, 2019, when the last participant started the open label treatment. In total, 4,084 patients signed informed consent and were prescribed treatment. Baseline characteristics of intolerant participants as compared to tolerant participants are shown in Table 1 . Mean age of participants was 65.3 years, 17.0% were female, and 3.0% were non-Caucasian. The majority had a body mass index ≥ 24 kg/m 2 (75.0%). Active smoking was reported by 15.4% of participants, 17.7% had diabetes and 60.4% had a history of myocardial infarction. The majority had an estimated glomerular filtration rate > 60 ml/min/1.73m 2 and 10.4%were known to have left ventricular ejection fraction < 50%. Secondary preventive treatment was accurate to contemporary standards, with 92.9% of participants using statin therapy, antiplatelet therapy or anticoagulation used by 99.6% of participants and frequent use of beta-blocker and calcium channel blockers. Adherence and perceived side effects Of the 4,084 patients that were prescribed the open label drug, 3,618 patients were randomized. In the remaining 466 patients, 322 (8.9%) were reported to be intolerant to the drug, 28 were incompliant with the drug regime and 116 (2.8%) did not proceed to the randomized phase of the trial for other reasons. The 322 patients reported 354 different side effects ( Figure 1 ). The most common side effects were gastro-intestinal upset (198, 53.9%), myalgia (61, 17.2%), fatigue (31, 8.8%) and non-specific symptoms (22, 6.2%). Skin problems, headache, vertigo, pharyngeal, symptoms were uncommon and composed less than 5% of total reported side effects. Myalgia and fatigue were more common in female patients than in male patients. ( Table 2 )