Attachment 2: Extract from the Clinical Evaluation Report ...

Secondary objectives of study LVHG were to examine if a dose-response relationship exists for placebo and tadalafil 2.5 mg, 5 mg, 10 mg and 20 mg once daily for 12 weeks in the treatment of BPH-LUTS, to test the hypothesis that tadalafil 2.5 mg, 5 mg, 10 mg and 20 mg once daily for 12 weeks is superior to placebo in the treatment of BPH-LUTS ... ................
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