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2.1 Renal Impairment Study 2.1.1 Study Population Male and female participants of non-childbearing potential were eligible for inclusion in the renal impairment study if they were aged between 18 and 80 years with a body mass index (BMI) between 20 and 39.9 kg/m 2 and a body weight 60 kg at screening

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Prescriptions are issued only when clinically appropriate after provider evaluation and under physician supervision

The most critical limitation was that the number of participating patients was not sufficiently large to generalize these results and apply them to real clinical practice and that clinical data and sera samples from the time of diagnosis were used retrospectively