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Baseline tumour assessments were performed no more than 4 weeks before the start of study treatment.
Tumour progression had to be demonstrated within 6 weeks before the start of study treatment.
Written informed consent was obtained from all study participants before the start of study participation.
One patient withdrew informed consent before the start of study treatment.
Written informed consent was obtained from all the participants before the start of study.
A loading dose was not necessary if patients received trastuzumab within 2 weeks before the start of study treatment.
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The institutional review boards at the participating centers reviewed and approved the study before the start of any study procedures.
There were drop-outs both before the start of the study and during the study.
The Ethical Committee of the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Italy, approves the study protocol before the start of the study.
28 29 This analysis requires that neither the exposed nor unexposed patients are treated with the study drug before the start of the study.
This assumption holds only when neither the exposed nor unexposed patients have been treated with the study drug before the start of the study.
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