Correction for: Efficacy and safety of recombinant human follicle-stimulating hormone in patients undergoing in vitro fertilization-embryo transfer

Table 1. Baseline characteristics (MFAS population).

7^th row: The unit “month” for the “Duration of infertility” was corrected to “year”, making it consistent with the Supplemental Clinical Study Final Report.

13th row: The p-value (0.242) for “Fertilization procedure, n (%)” was corrected to “0.212”. In addition, a footnote “b” (The total number of evaluable patients was 110 in the Gonal-F® Pen group)” was added.

RESULTS, Patients

The p-value in the last sentence in the Patients section was changed from p = 0.242 to p= 0.212.

Corrected sentence: “The distribution of the patients according to fertilization procedure was similar between the groups (p= 0.212).” This is now consistent with value in the corrected Table 1.

RESULTS, Efficacy – Primary outcome

In the first sentence of the “Primary outcome” section, the abbreviation "±SD” was corrected to "±SE”, and the number 13 was corrected to 13.5. This SE value was estimated from an ad hoc analysis for this manuscript; the analysis source (SAS output) is available. The number 13.5 was based on a result from the Clinical Study Final Report (Table 15, available).

Corrected sentence: “The least square mean (±SE) number of oocytes retrieved was 14.9 (± 0.5; median [range]: 14 [1 to 41]) in the Follitrope group and 12.8 (± 0.9; median [range]: 13.5 [3 to 33]) in the Gonal-F group, showing a treatment difference of 2.1 oocytes.”

RESULTS, Efficacy – Secondary outcome

A subtraction error was corrected in the following sentence, which changed 44.3% to 44.6%.

Corrected sentence: “In the Follitrope group, 186 patients (55.4%) underwent ET in contrast to 79 patients (71.8%) in the Gonal-F group; thus, the cancellation rate was 44.6% and 28.2% in the Follitrope and Gonal-F groups, respectively (p = 0.0028).”

A numerical error was also corrected in the following sentence, which changed 35.3% to 35.5%.

Corrected sentence: “The percentage of embryos that were successfully implanted in patients showing gestational sacs (i.e., implantation rate) was 39.8% in the Follitrope group and 35.5% in the Gonal-F group (p = 0.376).” This correction makes the stated numbers consistent with Table 2.

Table 2. Efficacy outcomes (PP population).

3rd and 4th rows: For “No. of follicles with diameter of ≥14 mm on hGC day” and “E2 concentration on hGC day, pg/mL), a footnote “a” was added based on the final result from the Clinical Study Final Report (Tables 26 and 36).

5th row: For “No. of oocytes retrieved” the footnote “c” (Values are mean±SE)” was added, as requested above for the “Primary outcome” section in the RESULTS. In addition, the p-value was corrected from “0.022” to “0.057” based on the final result from the Clinical Study Final Report (Table 16).

Corrected Tables 1 and 2 are presented below.