Amarin Corp Plc (AMRN)

[HDGabor]

y-

Yes, JELIS wasn't a double blinded trial ... but it wasn't a full open label.

we used an open interventional design, with blinded clinical endpoint assessment (PROBE design) to keep bias to a minimum.23 The PROBE design has the advantages of low costs and similarity to standard clinical practice, which should make the results easily applicable in routine medical care; however, we cannot exclude the possibility of bias in some of the physician-initiated endpoints, such as coronary revascularisation and hospital treatment for unstable angina. ... Local physicians monitored compliance with dietary advice and medication, and noted adverse events at every clinic visit. Clinical endpoints and severe adverse events reported by local physicians were checked by members of a regional organising committee in a blinded fashion. Then, an endpoints adjudication committee (see webappendix), consisting of three expert cardiologists and one expert neurologist, con? rmed them once a year without knowledge of the treatment allocation.

Best,
G