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The software programs ADAPT 5 and PFIM were used to design an optimal sampling strategy for a future phase II/III darbepoetin alfa neonatal trial in Appendices 3 and 4, respectively.
The purpose of this trial is to establish appropriate outcome measures that can be used to calculate power for a future phase II randomised-controlled trial for the same intervention.
It is the intention of this study to form the basis for a future phase III trial comparing conventional radiotherapy with radiosurgery for palliation of painful vertebral metastases in a randomized manner.
Optimise the data collection and analysis procedures for a health economic analysis for a future Phase III RCT.
The results will inform the sample size calculation for a future Phase III RCT.
46 This will inform decisions about outcome measures for a future phase III trial.
Erlotinib may be considered the best candidate for a future phase III trial of targeted therapy.
The effect size of WOMAC and IPAQ will inform the sample size calculation for a future phase III trial.
This open-label phase I dose-finding study evaluated the safety dose of erlotinib in combination with pemetrexed for a future phase II study.
Thus, for a future phase II study with indisulam and carboplatin in chemotherapy naïve patients with NSCLC, a 4-weekly schedule was proposed.
We will also calculate the effect sizes of key outcomes including condom use over the past 3 months, to inform power calculations for a future phase III RCT.
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