Table 1 Safety—serious and non-serious adverse events up to 6 months post intervention

Number of patients

20

20

100

Serious adverse event

0 (0)

0 (0)

0 (0)

Loss of injection product (n)

0 (0)

0 (0)

0 (0)

Total volume injected (mL)

3

6

20

Injection of allocated amount of product (n)

20 (100)

20 (100)

100 (100)

Adverse event                                                                                                                                          

n(%)

n(%)

n(%)

 Pain at harvest site^a

5 (25)

7 (35)

9 (9)

 Pain at injection site^a

6 (30)

6 (30)

5 (5)

 Brushing at harvest site^a

5 (25)

5 (25)

6 (6)

 Bruising at injection site^a

3 (15)

4 (20)

4 (4)

 Negative impact on penis^b

0 (0)

0 (0)

0 (0)

 Fevers

0 (0)

0 (0)

0 (0)

 Infection

0 (0)

0 (0)

0 (0)