Start and Duration. The TRIAL will not be initiated unless the mandatory permission of the Spanish Agency for Drugs and Health Products (“Agencia Española de Medicamentos y Productos Sanitarios”, AEMPS, from now on) has been issued. The parties commit themselves to make sure that the TRIAL is conducted as specified by the PROTOCOL, and specifically, not to start the TRIAL without the permission of the AEMPS. The estimated duration of the TRIAL is ________ months from the date of the AEMPS permission, as indicated in the protocol. In case of competitive recruitment, the number of the recruited subjects may differ from the number originally planned.
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