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No significant change in adherence (overall mean 81.0%; 95% CI 77.5%-84.6%; p = 0.728), condom use (p = 0.077) and number of sexual partners (overall mean 2.36 per 30 days; 95% CI 2.06 to 2.65; p = 0.235) was found throughout the study. Participants reported 110 graded adverse effects (AE), 104 (94.5%) grade 1-2 and 6 (5.5%) grade 3-4. No participant discontinued PrEP due to AE. The study showed successful implementation of PrEP among MSM at high risk for HIV infection in Slovenia. Based on the results of our study, PrEP should be form