References

International Conference on Harmonization (1997) Good clinical practice: consolidated guideline. Fed Reg 62 (90).

International Conference on Harmonization (1997) Draft guideline on general considerations for clinical trials. Fed Reg 62 (104).

International Conference on Harmonization (1996) Guideline on the structure and content of clinical study reports. Fed Reg 61 (138).

Spilker B (1991) Guide to Clinical Trials. Raven: New York.

Section II

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