The dosage used was based on the reported maximal GH stimulation in human volunteers (Wren et al, 2001) and on prior trials using up to 10 μg kg−1 in healthy volunteers and 6 μg kg−1 in patients (Nagaya et al, 2001b).
Mean differences (and standard deviations) of this magnitude, and this potential attrition rate are more conservative than a prior intervention trial using these same outcome measures (but evaluating a clinic only based intervention) and our own pilot investigations [ 15, 28].
Stopping guidelines for efficacy were agreed upon by the DSMB members and the investigating team prior to the trial, using Lan-DeMets boundaries and nominal p-values for group sequential analyses estimated using O'Brien/Fleming spending function[ 17, 18].
Allocation sequences will be generated in permuted block sizes of 6, 8, or 10 by study personnel prior to beginning the trial using a web-based randomization generator http://www.randomization.com.
The BU/FTBI/VP-16 combination was first tested by our group in a Phase I/II trial using oral busulfan prior to the availability of IV BU.
However, all prior clinical trials using PGS for IVF have used FISH, which screens for a minority of chromosomes.
The results of ADaPT are in principal agreement with prior randomized trials using ACE inhibitors or angiotensin receptor blockers (Table 5).
The computer-generated randomization list was produced prior to the start of the trial using randomly varying block sizes.
An allocation assignment schedule will be prepared prior to commencement of the clinical trial using random numbers generated with the ralloc command in the Stata statistical package [ 29].
Randomization was done prior to the start of the trial using computer-generated random patient allocation in blocks of four for each participating surgeon (Block Stratified Randomization version 4.4, 1997; S. Piantadosi, Baltimore, Maryland).
