If either Visit 4 or Visit 7 is extended beyond 28 days but within the protocol allowed + 3 day visit window, should study medication use also be extended for the same period of time?
Yes, study medication should continue to be taken up to and including the evening of the day on which Visit 4 or 7 takes place. There is sufficient overage in the study medication bottles to allow for this.
How large is the pill the subjects need to swallow? Can it be cut for easier swallowing?
The tablets are small – only around 10 mm (1/8th of an inch) in diameter and 4 mm (1/16th of an inch) thick, so are sufficiently small that practically every patient should be able to swallow them whole without the need to cut them. We advise the patients to swallow the pill whole to ensure […]
Can patients have a “drug holiday” or can dosing be inturrupted during either of the dosing periods?
If a subject experiences an AE which the investigator believes is treatment related and which the subject finds intolerable, a break in dosing of up to 1 week is permitted. If on reintroduction of the IMP, the AE recurs and remains intolerable the IMP will then be withdrawn altogether. A break in dosing will not […]