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AstraZeneca Group of Companies allows researchers to submit a request to access anonymized patient level clinical data, aggregate clinical or genomics data (when available), and anonymized clinical study reports through the Vivli web-based data request platform.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"All studies were conducted in accordance with the ethical principles set forth in the Declaration of Helsinki, the International Conference on Harmonisation guideline regarding Good Clinical Practice (E6 Consolidated Guidance, April 1996), and the ethical requirements referred to in the European Union Directive 2001\/20\/EC. The institutional review boards or ethics committees of the study sites approved the study protocols. 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