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. 2010 Nov;8(6):542–549. doi: 10.1370/afm.1174

Table 1.

Study Eligibility Criteria

Component Description
Population Adults and children with type 1 or type 2 diabetes
Intervention Pramlintide for FDA- and non-FDA-approved indications
Compared agent Other hypoglycemic agent or placebo
Long-term health outcomes All-cause mortality, micro- or macrovascular disease, quality of life, complications related to diabetes
Intermediate outcomes Glycemic control: HbA1c, fasting plasma glucose, postprandial glucose; change in weight; time to treatment failure
Harms-related outcomes Withdrawals due to all causes, withdrawals due to adverse events, overall adverse events, major adverse events
Study design For efficacy/effectiveness: randomized controlled clinical trials, good-quality systematic reviews
For harms and subgroups: randomized controlled clinical trials, good-quality systematic reviews, population-based comparative cohort or case-control studies
Excluded Trials <12 weeks’ duration; abstracts, posters, and conference proceedings with limited information for quality assessment

FDA = Food and Drug Administration; HbA1c=glycated hemoglobin.