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All SAEs of death, development of signs of critical illness and severe illness requiring hospitalisation, and AEs as described previously will be reported to the Ethics Committees, the Data and Safety Monitoring Board (DSMB) and to the sponsors of the study within 24 hours of awareness of the event, followed by a final report within 10 days

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Food and Drug Administration (FDA), with indications that include cosmetic correction of penile soft tissue deformities [19] and cosmetic enhancement of the penis [20]

Tissue injury was evaluated microscopically by a blinded examiner using an Olympus BX51 microscope and Olympus 71 digital camera, saving images as uncompressed 24-bit RGB TIFF files

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