4 Analysis Data Sets

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The analysis of all primary and secondary endpoints is based on the set of all 3431 evaluable patients. For more details and exceptions concerning individual analyses see 6.2 and 6.4.

As a supportive analysis, selected endpoints, in particular those related to the primary objectives of the investigation, were evaluated for the following patient subset:

4.1 First ESP Year Set

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While only 42 centres participated in the ESP in the first year, 60 centres transplanted ESP patients as of the second year. Given that in the first year, centres only gradually adjusted to the new program, the outcome for patients transplanted in the first year (4 January 1999 to 4 January 2000) was analyzed separately for comparison with both of the control groups as well as the complete 5 year analysis. In the results section that follows, only the results that are different from the main analysis or from the first year results published by Smits in 2002 (Smits, et al., 2002) are reported.


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