Hi,
I would like to ask about requirement regarding "quantity of dosage units". Is it possible to justify lack of this information if the trial has a different dosage during the duration and also adaptive design suggests high possibility of changing the established doses? How should I overcome this issue? There will be one bottle with liquid medication and the doses will change first after two weeks and then accordingly to the data collected. I would appreciate your help and advice on that,
Many Thanks,
Marta