No studies were submitted that assessed safety as a primary outcome.
Not applicable.
Not applicable.
Safety data was analysed in the Safety Dataset which comprised of all patients who took at least one dose of the study drug. In the ivabradine group, the mean ( SD) treatment duration was 20.0 ( 9) months and 65.4% of the patients had a treatment duration of at least 18 months and 35.3% of at least 24 months (Table 13). The mean ( SD) doses of ivabradine prescribed according to treatment duration and follow-up duration were 6.4 ( 1.4) mg twice daily and 5.8 ( 2.1) mg twice daily, respectively (Table 14).
Table 13. Treatment durations in the Randomised Set
Table 14. Mean dose of study drug prescribed in the Randomised Set
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