Concomitant medication. The following medications may only be administered as indicated: · ceftriaxone may not be administered during the 48 hours immediately prior to the administration of BL-1040, and for the 48 hours immediately following administration of BL-1040 · calcium solutions may not be administered during the first week of the study The introduction of any medication not allowed by the protocol at any point in the study will require a discussion between the Investigator and the Sponsor. If, in the opinion of the Investigator, it becomes necessary to administer any medication during the study, the Investigator will determine the dose and time of intake, and document the medication(s) in the patient’s CRF. Patients must be instructed not to begin any new medication before consulting with the Investigator (unless required for emergency medical use). The patient must be instructed that this prohibition applies to over-the-counter products as well as prescription drugs. All patients will receive optimal medical therapy according to the relevant, updated guidelines from the European Society of Cardiology [3,4,5]. Optimal therapy including aspirin, anticoagulation if indicated, angiotensin-converting-enzyme inhibition, beta-blockade, aldosterone antagonists, when appropriate, and lipid-lowering therapy, unless contraindicated. Clopidogrel therapy will be initiated before PCI and continued for 1 year after myocardial infarction [3].
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Samples: License and Commercialization Agreement (Bellerophon Therapeutics, Inc.), License and Commercialization Agreement (Bellerophon Therapeutics LLC), License and Commercialization Agreement (Bellerophon Therapeutics LLC)