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Indeed during the conduct of our trial our institution decided to close the hydrotherapy facility.
Ideally the strategies used should be tailored to the factors specific to the trial and institution.
Trials of different recruitment strategies could be embedded in large multicentre RCTs, with strategies tailored to the factors specific to the trial and institution.
Reviewers were not blinded to trial authors, institutions, journal of publication, and results of study.
The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2407/13/454/prepub wantantothankall all patients who participated in this trial, all institutions who included patients, and all the staff engaged in this study, especially the study team at GSO Hamburg (Gesellschaft für Studienmanagement und Onkologie mbH).
It may reflect the fact that (i) our initial doses of chemotherapy were relatively low, (ii) more conformal radiotherapy techniques were used, (iii) these large phase III trials were multicentre trials and ours is a single institution trial with strict monitoring of the patients, and (iv) underscores the importance of intense supportive care (Macdonald et al, 2001; Cunningham et al, 2006a).
The institutional review board or ethics committee for each participating institution trial reviewed and approved the trial.
Nevertheless, after passing this decision, the court forwarded the collected material to the pre-trial investigation institutions regarding the assessment of the legality of the company's activity, i.e. to potentially impose criminal liability on the company.
In these trials volunteer institutions may be atypically well resourced or experienced, successful innovators.
These manual procedures are expensive and can result in high phenotypic and yield variability between different trials and institutions [ 5].
Thus, coordination of trials among institutions and cooperative groups, both nationally and internationally, will be the key to improving treatment outcomes in BTCs.
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