Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the serious adverse event and the preceding performance study has been established.
D'ainneoin mhír 5, beidh feidhm ag an Airteagal seo i gcás inar cruthaíodh gaolmhaireacht chúise idir an tarlú díobhálach tromchúiseach agus an staidéar feidhmíochta a chuaigh roimhe.