| General | |
| Method | Study design. Participants. Sample size, loss to follow-up. Characteristics of participants at baseline as age, sex, body mass index, cardiovascular comorbidities, cardiovascular risk factors, co-medications with influence on the cytochrome of interest, history of adverse reaction to multiple medications, lipid profile, past achievement of LDL-C goals; creatine kinase, liver function test, intolerance, SAMS.
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| Intervention and control | Statins, doses, timing, frequency, length of intervention, washout period, duration of follow-up. Description of co-interventions, lifestyle modification, modification of baseline medication regimen. Types of comparator, doses, timing, frequency, intervention protocols, length of intervention, washout period, duration of follow-up.
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| Outcomes | Proportion of population with/without muscles symptoms-related adverse events, time to muscles symptoms-related adverse events, proportion of population with muscles symptoms related drop out, lipid profile, creatine kinase level, liver function test. Multiple adverse events occurrence in the same individuals. All other adverse outcomes and collection systematic: definition of each adverse outcome addressed, method of ascertainment (patient report vs active search), method of measurement, timing and frequency of adverse events, measurement of the severity. Associated factor to the adverse events. For each outcome at each time point: number of participants randomly assigned and included in the analysis; number of participants who withdrew, were lost to follow-up or were excluded with reasons for each.
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| Notes | |