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The safety sample will be used for this analysis.
Safety and tolerability variables were summarized descriptively for the safety sample.
Data analysis will be by ITT, by protocol and by safety sample.
The safety sample comprised all randomised patients who took at least one dose of study medication.
The safety sample consists of all participants who received at least one study treatment.
The safety sample comprised all subjects allocated to treatment who took at least one dose of pancreatin or placebo.
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Expressing HEV capsid proteins by baculovirus and insect cells helped to bypass the issue of safety and sample shortage.
For safety, the sample size calculation is based on superiority of each of the two test dose arms to the comparator arm (0.75 mg/kg).
An interim analysis by an external data monitoring committee is scheduled in the near future and will consider intervention efficacy, safety and sample size.
In conclusion, this pilot study has provided the feasibility, safety and sample size for a full-scale trial of acupuncture with NSAIDs for chronic neck pain in comparison with acupuncture or NSAID treatment alone.
At each study site, two midwives were trained for 2 days on study procedures, facts on HBV infections and transmissions, counselling, safety issues, sample collection and transportation as well as site testing for HBsAg.
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