when it considers that participation in the performance study would lead to a subject receiving treatment inferior to that received in normal clinical practice in that Member State concerned;
nuair a mheasann sé go bhfágfadh rannpháirteachas sa staidéar feidhmíochta go bhfaigheadh an t-ábhar cóireáil ar cháilíocht níos ísle a fháil ná mar a gheobhadh sé sa ghnáthchleachtas cliniciúil sa Bhallstát sin lena mbaineann;