br Dr Shore as the principal investigator
Dr. Shore, as the principal investigator of this trial, was involved in study design, interpreted the data, and reviewed the drafts of the manuscript. Dr. Parente was responsible of the project conceptualization and was involved in the clinical trial study design. Moreover, he was the project leader for the development of leuprolide acetate formulation. Ms. Sanahuja and Dr. Guerrero managed the project at the sponsors site; in addition, they contributed, together with Dr. Gambús and Dr. Parente, to analysing the data, writing the
manuscript, and creating figures. All authors were involved in the decision to submit the article for publication; accordingly, they read and approved the final version of the manuscript. The sponsor was not involved in the collection and interpretation of study data. Study collection and writing the clinical study report were performed by a contract research organization.
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