The protocol does not specifically address this scenario so each subject should be considered on a case by case basis, taking into account the reason for discontinuation. The most likely reason for discontinuation is intolerability in which case the screening visit can be scheduled once the drug is fully washed out (only ~2 days for pirfenidone and ~4 days for nintedanib) and the side effects leading to discontinuation have fully resolved. If the drug has been withdrawn for other reasons, for example disease progression, then these wash-out periods apply but the suitability of the patient for the study must be considered in relation to other selection criteria (for example IC 7, life expectancy of >1 year).
