Non-compartmental MPA pharmacokinetic parameters were derived from individual plasma concentration-time profiles using WinNonLin 5.2 software. The areas under the curve were calculated by means of the linear trapezoidal rule.

Pharmacokinetic profiles were performed only in patients involved in Phase I of the study. The pharmacokinetic population consisted of 42 participants.

Median time to first occurrence of treatment failure was not reached in this study.

Rates for all individual components of the primary endpoint 'treatment failure' until day 180:

• Acute rejection diagnosed by biopsy (BPAR)
• graft loss
• death
• loss to follow up
• discontinuation from study drug due to lack of efficacy or toxicity (adverse events, every adverse event had to be interpreted as toxicity)
• conversion to another dosing regimen (conversion to tacrolimus, prograf, etc.)

Intent-to-treat population

Due to a small number of events, median time to <event> was not reached.

Due to a small number of events, median time to <event> was not reached.

Treatment failures were defined as a composite endpoint of biopsy proven acute rejection (BPAR), graft loss, and death, loss to follow up and discontinuations from study drug treatment due to lack of efficacy or toxicity (at least one condition must be present) during the first 6 months or until final assessment. Any participants who were suspected of having acute rejection episodes had biopsies performed to prove whether a rejection had occurred. Graft loss was considered as the day the patient started dialysis and was not able to subsequently be removed or the day of graft nephrectomy.

The Glomerular Filtration Rate (GFR) was calculated using the following formulas:

• Cockcroft-Gault formula: calculation using the participant's age, gender, weight, and serum creatinine levels.
• MDRD formula: calculation using the participant's age, gender, serum creatinine, urea nitrogen, and albumin levels.

Intent-to-treat population for whom data was available. End of Study data was imputed using Last Observation Carried Forward (LOCF).