Is there a rationale for the number for ECG assessments throughout the protocol? Are there any events/observations that the sponsor is specifically looking to monitor with these assessments?
This is the first study undertaken with orvepitant in patients with IPF and so we need to take a more cautious approach with the safety assessments. There has also been an indication from previous studies that palpitations may be reported more commonly in orvepitant treated patients than placebo patients and so the frequent ECGs are […]
