Captain I agree that would have been the reason but seems excessive to run the full 6 months to declare safety ok when they already. Then have the results for the first 6 patients locked up in a draw for 12 months - should have at least been 6 patients reviewed at 6,12 and 18 months second set for 6 and 12 months and last set just 6 - much more data but same time .IMO
AGM, page-59
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