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The primary efficacy data set (modified intention-to-treat population) and safety data set consisted of all the patients who had undergone randomization and received at least one dose of a trial drug.No adjustment for multiple comparisons was performed for analyses of secondary efficacy outcomes and subgroup comparisons.
The primary efficacy data set (modified intention-to-treat population) and safety data set consisted of all the patients who had undergone randomization and received at least one dose of a trial drug. The secondary efficacy data set consisted of all the patients who had undergone randomization (intention-to-treat population) along with the per-protocol population; the latter consisted of all the patients in the intention-to-treat population who completed the trial in full compliance with the protocol and without any major deviation. No adjustment for multiple comparisons was performed for analyses of secondary efficacy outcomes and subgroup comparisons.
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