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‡ EudraCT: 2013‐000632‐94, 2012‐004827‐19, 2012‐004826‐92, 2013‐004392‐12, 2013‐004502‐26, 2012‐002839‐28, 2015‐005622‐19, 2015‐005209‐36, 2015‐001351‐71, 2015‐005210‐30, 2015‐005326‐19, 2015‐003563‐10, 2015‐005593‐38, 2016‐000988‐16