A multicenter, randomized phase III study of bortezomib and ...
A multicenter, randomized phase III study of bortezomib and ...
A multicenter, randomized phase III study of bortezomib and ...
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HOVON 104 AL AMYLOIDOSIS<br />
Clinical trial protocol version z. 2z Novemoer zotz<br />
SPONSOR AND PRINGIPAL INVESTIGATOR SIGNATURE PAGE<br />
The presentrial protocol was subject to critical review <strong>and</strong> has been approved in the present version<br />
by the persons undersigned. The information contained is consistent with:<br />
- the current risk-benefit assessment <strong>of</strong> the investigational medicinal product<br />
- the moral, ethical, <strong>and</strong> scientific principles governing clinical research as set out in<br />
the applicable version <strong>of</strong> Declaration <strong>of</strong> Helsinki <strong>and</strong> the principles <strong>of</strong> GCP.<br />
The local investigator will be supplied by the Sponsor with details <strong>of</strong> any significant or new finding<br />
including AEs relating to treatment with the investigational medicinal product.<br />
,'l '<br />
<strong>of</strong> Principal I nvestigator<br />
7i tle t /t'/ Z<br />
Date<br />
,' / ('" t t)A.'rt,, ttr'l<br />
Printed Name <strong>of</strong> Principal Investigator<br />
Signature <strong>of</strong> Sponsor - HOVON chairman Date<br />
Printed Name <strong>of</strong> Sponsor - HOVON chairman<br />
Page 2 <strong>of</strong> 75 E ud raCT-No: 20 1 0-021 445-42
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